Cryptococcosis

Allschwil, Switzerland, April 24, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, reported today that the sales of the antifungal Cresemba® (isavuconazole) in Japan exceeded the threshold triggering a sales milestone payment from its partner Asahi Kasei Pharma (AKP), amounting to approximately CHF 1.7 million. This is the second milestone payment from AKP to Basilea in consecutive quarters. David Veitch, Chief Executive Officer of Basilea, said: “We are very pleased with the continued strong Cresemba sales performance by our partner AKP. Japan is a key commercial market with significant growth potential in the long-term and the strong sales uptake in the country shows that Cresemba is meeting critical medical needs of patients with life-threatening fungal infections.” Cresemba is marketed in more than 70 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between January and December 2024 amounted to USD 562 million, a 19 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 About Cresemba® (isavuconazole) Cresemba, with the active ingredient isavuconazole, is an intravenous (i.v.) and oral azole antifungal. Basilea has entered into several license and distribution agreements for Cresemba covering approximately 115 countries. In Japan, the oral and intravenous formulations are approved for the treatment of adult patients with aspergillosis (invasive aspergillosis, chronic progressive pulmonary aspergillosis, and simple pulmonary aspergilloma), mucormycosis, and cryptococcosis.2 Isavuconazole is also approved in the European Union3, the United Kingdom4, the United States5, China and several additional countries including in the Asia Pacific region.6 About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This press release can be downloaded from www.basilea.com. References IQVIA Analytics Link, December 2024. In-market sales reported as moving annual total (MAT) in US dollar.PMDA List of Approved Drugs April 2022 to March 2023: https://www.pmda.go.jp/files/000267877.pdf [Accessed: April 23, 2025]European Public Assessment Report (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: April 23, 2025]Summary of Product Characteristics (SmPC) Cresemba: https://www.medicines.org.uk/emc/search?q=cresemba [Accessed: April 23, 2025]Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: April 23, 2025]The registration status and approved indications may vary from country to country. Attachments Press release (PDF)

RINVOQ is the first and only oral Janus kinase (JAK) inhibitor approved in the European Union (EU) to treat adult patients with giant cell arteritis (GCA) The approval is supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that RINVOQ achieved the primary endpoint of sustained remission* and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure and complete remission †1 This marks the eighth approved indication for RINVOQ in the EU2 NORTH CHICAGO, Ill., April 8, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) granted marketing authorization to RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of giant cell arteritis (GCA) in adult patients. RINVOQ is the first and only oral JAK inhibitor approved in the EU, as well as Iceland, Liechtenstein and Norway, for the treatment of adult patients with GCA. "GCA is a challenging and often debilitating condition. Patients may endure headaches, jaw pain and muscle aches, with many fearing sudden and permanent vision loss,"3 said Prof. Dr. med. Wolfgang Schmidt, M.D., MACR, Waldfriede Hospital, Department of Rheumatology, Berlin, Germany, and SELECT-GCA trial investigator. "Results from the SELECT-GCA trial show that patients can achieve sustained remission and reduce their cumulative steroid exposure with RINVOQ, addressing important patient goals in the treatment of GCA." GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries. GCA generally impacts patients older than 50 years, most commonly between the ages of 70 and 80 years.3 "The EC approval of RINVOQ in GCA provides patients and physicians with a new treatment option and the first oral advanced therapy for adults living with GCA – a particularly vulnerable population due to older age and frequent comorbidities,"3,4 said Roopal Thakkar, M.D., executive vice president, research & development, chief scientific officer, AbbVie. "This exciting milestone demonstrates our commitment to ongoing research and expanding indications in areas of high unmet need to help patients achieve better outcomes, including sustained disease remission." The EC approval is supported by data from the Phase 3 SELECT-GCA trial, which was recently published in the New England Journal of Medicine.1 In this trial, primary and key secondary endpoints were achieved with RINVOQ 15 mg and a 26-week steroid taper regimen compared to placebo in combination with a 52-week steroid taper regimen.1 Primary endpoint results from the Phase 3 SELECT-GCA trial demonstrated: Sustained remission*: 46.4% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission at week 52, compared with 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.002).1 Key secondary endpoints included: Reduction in disease flares: 34.3% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen experienced at least one disease flare through week 52 versus 55.6% of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.001).1 Lower cumulative steroid exposure: Through 52 weeks, cumulative steroid exposure was significantly lower for patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen than for patients receiving placebo in combination with a 52-week steroid taper regimen (median exposure of 1615 mg versus 2882 mg, respectively; p<0.001).1 Sustained complete remission†: 37.1% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen achieved sustained complete remission through week 52, compared with 16.1% of patients receiving placebo in combination with a 52-week steroid taper regimen (p<0.001).1 During the 52-week, placebo-controlled period, the safety profile of RINVOQ was generally consistent with that observed in other approved indications.2 Similar rates of serious adverse events were observed in patients receiving RINVOQ 15 mg and in those receiving placebo.1 Serious infections occurred in 5.7% of the RINVOQ 15 mg group and 10.7% of the placebo group.1 The proportions of patients with events of interest were balanced across treatment groups for incidence of malignancy (excluding nonmelanoma skin cancer; 1.9% in the RINVOQ 15 mg group vs 1.8% in the placebo group) and venous thromboembolism (3.3% in the RINVOQ 15 mg group vs 3.6% in the placebo group).1 There were no adjudicated major adverse cardiac events (MACEs) in the RINVOQ 15 mg group, compared with two events in the placebo group.1 Four treatment-emergent deaths were reported, two in the placebo group and two in the RINVOQ 15 mg group. Of the two treatment-emergent deaths in the RINVOQ 15 mg group, one was attributed to COVID-19 and the other was adjudicated as an unexplained cause.1 RINVOQ is approved in the EU for the treatment of adults with radiographic axial spondylarthritis, nonradiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, adults and adolescents with atopic dermatitis, and now adults with GCA.2 *Sustained remission is defined as having an absence of GCA signs and symptoms from week 12 through week 52 and adherence to the protocol-defined steroid taper over the course of the study term.1 †Sustained complete remission is defined as having an absence of GCA signs and symptoms from week 12 through week 52, adherence to the protocol-defined steroid taper, and normalization of both erythrocyte sedimentation rate and high-sensitivity C-reactive protein from week 12 through week 52.1 About Giant Cell Arteritis Giant cell arteritis (GCA), also known as temporal arteritis, is an autoimmune disease of medium and large arteries, characterized by granulomatous inflammation of the three-layered vessel wall, which affects temporal and other cranial arteries as well as the aorta and other large arteries.3,5 GCA can cause headache, jaw pain, and changes in or loss of vision, including sudden and permanent loss of vision.3 It is the most common vasculitis affecting adults in western countries.3 White women over the age of 50 – most commonly between the ages of 70 and 80 years – have the highest risk of developing GCA. Although women are more likely than men to develop GCA, research suggests that men are more likely to have ocular manifestations with their disease.6 About SELECT-GCA SELECT-GCA (M16-852) is a Phase 3, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib in 428 patients with GCA. The study consists of two parts. The first part, which is reported in this release, evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared with placebo in combination with a 52-week corticosteroid taper regimen. In addition, the study assessed the safety and tolerability of upadacitinib in these patients. The efficacy and safety of withdrawing versus continuing upadacitinib in maintaining remission in participants who achieved sustained remission in the first part will be evaluated in the second part of the study.7 Top-line results of part one of the study were shared in April 2024. For more information regarding this study, please visit ClinicalTrials.gov (identifier: NCT03725202). About Upadacitinib (RINVOQ®) Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.2,8 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK 1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.2 Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo.9-14 EU Indications and Important Safety Information about RINVOQ® (upadacitinib)2 Indications Giant cell arteritis RINVOQ is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Rheumatoid arthritis RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate. Psoriatic arthritis RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate. Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Atopic dermatitis RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy. Ulcerative colitis RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Crohn's disease RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Important Safety Information Contraindications RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy. Special warnings and precautions for use RINVOQ should only be used if no suitable treatment alternatives are available in patients: 65 years of age and older; patients with history of atherosclerotic cardiovascular (CV) disease or other CV risk factors (such as current or past long-time smokers); patients with malignancy risk factors (e.g. current malignancy or history of malignancy) Use in patients 65 years of age and older Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients ≥65 years of age, as observed in a large randomised study of tofacitinib (another JAK inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients ≥65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily. Immunosuppressive medicinal products Use in combination with other potent immunosuppressants is not recommended. Serious infections Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients ≥65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available. Tuberculosis Patients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB. Viral reactivation Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted. Vaccination The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines. Malignancy Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised active controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥ 1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients ≥65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available. Hematological abnormalities Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management. Gastrointestinal Perforations Events of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from post-marketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids, or opioids). Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation. Major adverse cardiovascular events MACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients ≥65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. Lipids RINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Hepatic transaminase elevations Treatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. Hepatic transaminases must be evaluated at baseline and thereafter according to routine patient management. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded. Venous thromboembolism Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients ≥50 years of age with ≥1 additional CV risk factor, a dose dependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE. Hypersensitivity reactions Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy. Hypoglycemia in patients treated for diabetes There have been reports of hypoglycemia following initiation of JAK inhibitors, including RINVOQ, in patients receiving medication for diabetes. Dose adjustment of anti-diabetic medication may be necessary in the event that hypoglycemia occurs. Medication Residue in Stool Reports of medication residue in stool or ostomy output have occurred in patients taking RINVOQ. Most reports described anatomic (e.g., ileostomy, colostomy, intestinal resection) or functional gastrointestinal conditions with shortened gastrointestinal transit times. Patients should be instructed to contact their healthcare professional if medication residue is observed repeatedly. Patients should be clinically monitored, and alternative treatment should be considered if there is an inadequate therapeutic response. Giant Cell Arteritis RINVOQ monotherapy should not be used for the treatment of acute relapses as efficacy in this setting has not been established. Glucocorticoids should be given according to medical judgement and practice guidelines. Adverse reactions The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (≥2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA. The most commonly reported adverse reactions in AD trials (≥2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg in adolescents was similar to that in adults. With long-term exposure, skin papilloma was reported in adolescents in the RINVOQ 15 mg and 30 mg groups. The most commonly reported adverse reactions in the UC and CD trials (≥3% of patients) with RINVOQ 45 mg, 30 mg or 15 mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropenia, rash, pneumonia, hypercholesterolemia, bronchitis, AST increased, fatigue, folliculitis, ALT increased, herpes simplex, and influenza. The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA. Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ. The most common serious adverse reactions were serious infections. The safety profile of RINVOQ with long-term treatment was generally similar to the safety profile during the placebo-controlled period across indications. Overall, the safety profile observed in patients with GCA treated with RINVOQ 15 mg was generally consistent with the known safety profile for RINVOQ. This is not a complete summary of all safety information. See RINVOQ full Summary of Product Characteristics (SmPC) at Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie in Rheumatology For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals. For more information, visit AbbVie in rheumatology. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References Blockmans D, Penn SK, Setty AR, et al. A phase 3 trial of upadacitinib for giant-cell arteritis. N Engl J Med. Published online April 2, 2025; doi:10.1056/NEJMoa2413449. RINVOQ. Summary of Product Characteristics. AbbVie; 2025. Ameer MA, Peterfy RJ, Khazaeni B. Giant cell arteritis (temporal arteritis). Updated August 8, 2023. Mohammad AJ, Englund M, Turesson C, et al. Rate of Comorbidities in Giant Cell Arteritis: A Population-based Study. J Rheumatol. 2017;44(1):84-90. doi:10.3899/jrheum.160249 Weyand CM, Goronzy JJ. Immunology of giant cell arteritis. Circ Res. 2023;132(2):238-250. doi:10.1161/CIRCRESAHA.122.322128 Giant cell arteritis. Arthritis Foundation. Accessed January 9, 2025. AbbVie. Data on file: ABVRRTI78418. Pipeline. AbbVie. 2023. Accessed January 9, 2025. A study to evaluate the safety and efficacy of upadacitinib in participants with giant cell arteritis (SELECT-GCA). ClinicalTrials.gov identifier: NCT03725202. Accessed January 9, 2025. A study to evaluate the efficacy and safety of upadacitinib in participants with Takaysu arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov identifier: NCT04161898. Accessed January 9, 2025. Program to assess adverse events and change in disease activity of oral upadacitinib in adult participants with moderate to severe systemic lupus erythematosus (SELECT-SLE). ClinicalTrials.gov identifier: NCT05843643. Accessed January 9, 2025. A study to assess change in disease activity and adverse events of oral upadacitinib in adult and adolescent participants with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy (Step-Up HS). ClinicalTrials.gov identifier: NCT05889182. Accessed January 9, 2025. A study to assess adverse events and effectiveness of upadacitinib oral tablets in adult and adolescent participants with vitiligo (Viti-Up). ClinicalTrials.gov identifier: NCT06118411. Accessed January 9, 2025. A study to evaluate the safety and effectiveness of upadacitinib tablets in adult and adolescent participants with severe alopecia areata (UP-AA). ClinicalTrials.gov identifier: NCT06012240. Accessed January 9, 2025. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Late-breaking results presented at AAD show 80% or more scalp hair coverage at Week 36 in 42.4% of adolescents receiving baricitinib 4 mg Patients treated with baricitinib 4 mg saw significant regrowth of eyebrows and eyelashes at Week 36 compared to placebo Positive data underscore Lilly's continued expansion across dermatologic conditions, with treatments that can improve outcomes for patients with the greatest need INDIANAPOLIS, March 8, 2025 /PRNewswire/ -- Late-breaking results from Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) found adolescent patients (ages 12 to under 18) with severe alopecia areata (AA) treated with once-daily, oral baricitinib 4 mg and 2 mg saw clinically meaningful improvements in hair regrowth on the scalp, eyebrows and eyelashes at Week 36. Findings from the Phase 3 BRAVE-AA-PEDS study were presented in a late-breaker presentation at the American Academy of Dermatology (AAD) Annual Meeting taking place March 7-11 in Orlando.1 AA is an immune system condition that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress over time. Approximately 40% of patients with AA experience first onset by 20 years of age.2 "Early onset alopecia areata can be more severe, leading to extensive hair loss that frequently does not improve with topicals or corticosteroids often prescribed as first-line therapy," said Brittany Craiglow, M.D., Adjunct Associate Professor of Dermatology, Yale School of Medicine. "These initial results are exciting because they demonstrate that baricitinib can provide significant hair regrowth for adolescents at 36 weeks, a promising early signal of baricitinib's potential as an effective treatment for adolescents with severe disease." In the BRAVE-AA-PEDS study, 257 patients were randomized to receive once-daily baricitinib 4 mg, baricitinib 2 mg or placebo. The primary endpoint of this study was a Severity of Alopecia Tool (SALT) score ≤20 (i.e., 80% or more scalp hair coverage) at Week 36. At the start of the study, patients had an average of 89% scalp hair loss (near total hair loss), 65% had minimal or no eyebrow hair (clinician-reported outcome [ClinRO] score of 2 or 3) and 57% had minimal or no eyelash hair (ClinRO score of 2 or 3).1 At Week 36: 60.0% of patients receiving baricitinib 4 mg and 36.9% of patients receiving baricitinib 2 mg saw at least a 50% improvement in their disease (as measured by SALT score) compared to 5.7% on placebo (p=0.001). 42.4% of patients receiving baricitinib 4 mg and 27.4% of patients receiving baricitinib 2 mg achieved 80% or more scalp hair coverage, compared to 4.5% on placebo (p=0.001). 36.5% of patients receiving baricitinib 4 mg and 21.4% of patients receiving baricitinib 2 mg had 90% or more scalp hair coverage (SALT ≤10), compared to 2.3% on placebo (p=0.001). 50.0% of patients receiving baricitinib 4 mg and 24.1% of patients receiving baricitinib 2 mg achieved significant eyebrow regrowth (ClinRO scores of 0 or 1 with a ≥2 point improvement from baseline) compared to 0% on placebo (p<0.01). 42.9% of patients receiving baricitinib 4 mg achieved significant eyelash regrowth, and 25.5% receiving baricitinib 2 mg saw improved eyelash regrowth, compared to 14.0% on placebo (p=0.002 for 4 mg, p=0.097 for 2 mg).1 Results achieved by adolescents at 36 weeks were comparable to results achieved by adults after 52 weeks of treatment, suggesting that hair regrowth may be faster in adolescents compared to adults.1 In the BRAVE-AA1 and BRAVE-AA2 studies, 40.9% of adult patients treated with baricitinib 4 mg and 21.2% of patients treated with baricitinib 2 mg achieved 80% or more scalp hair coverage at Week 52.3 "With these data, baricitinib is the most well-studied JAK inhibitor in severe alopecia areata, a chronic immune system disorder that can have an especially devastating social and emotional impact on adolescent patients and their families," said Anabela Cardoso, senior vice president, Lilly Immunology Medical Affairs. "We are excited about these initial results, which show baricitinib can provide significant scalp hair regrowth in adolescents, potentially at an even faster rate compared to adults. We look forward to sharing longer-term data results at upcoming congresses and discussing findings with global regulators in the months ahead." The most common treatment-emergent adverse events in BRAVE-AA-PEDS included acne, influenza and upper respiratory tract infection. A higher frequency of serious adverse events was seen in the placebo group compared to baricitinib groups. No deaths, opportunistic infections, major adverse cardiovascular events, venous thromboembolic events or malignancies were reported in the trial.1 The safety profile of baricitinib in adolescents with AA was consistent with the safety profile seen in clinical trials for adolescent patients with juvenile idiopathic arthritis and moderate-to-severe atopic dermatitis. Over 14,600 patients have received baricitinib in clinical trials; of these, 866 have been patients between the ages of >1 month to <18 years. Lilly will present additional data from the BRAVE-AA-PEDS study at scientific meetings later this year and submit the results for peer-reviewed publication. Baricitinib is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. In 2022, the U.S. Food and Drug Administration (FDA) approved baricitinib (commercially available as Olumiant) for adult patients with severe AA, making it the first systemic treatment approved in the U.S. for severe disease. Baricitinib is also approved in the U.S. and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis, in more than 40 countries for the treatment of patients down to the age of two with moderate-to-severe atopic dermatitis who are candidates for systemic therapy and in Europe and Japan for adult patients with severe AA. Marketing authorization for the treatment of hospitalized patients with COVID-19 has been granted for baricitinib in multiple countries. About BRAVE-AA-PEDS Study BRAVE-AA-PEDS (NCT05723198) is an ongoing, placebo-controlled, Phase 3 trial involving children ages 6 to under 18 years with severe AA, as measured by a Severity of Alopecia Tool (SALT) score of ≥50 (i.e., who had ≥ 50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years. Adolescent participants were randomized in a 1:1:1 ratio to receive once-daily placebo, baricitinib 4 mg or baricitinib 2 mg. The first cohort of patients enrolled included adolescents (ages 12 to under 18 years, weighing ≥ 30 kg). The next cohort of children ages 6 to under 12 will begin enrollment in the next year. An additional cohort of adolescents were randomized 1:1 to baricitinib 4 mg or baricitinib 2 mg. IMPORTANT SAFETY INFORMATION FOR OLUMIANT (BARICITINIB) TABLETS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include: Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use. Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral, and other infections due to opportunistic pathogens. Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection. The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered. Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant. MORTALITY In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant. MALIGNANCIES Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers. NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer. MAJOR ADVERSE CARDIOVASCULAR EVENTS In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction [MI], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur. THROMBOSIS Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis. HYPERSENSITIVITY Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction. GASTROINTESTINAL PERFORATIONS Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation. LABORATORY ABNORMALITIES Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management. In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3. Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management. In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3. Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management. In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL. Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded. Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia. VACCINATIONS Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines. ADVERSE REACTIONS In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster. In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection. In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase. PREGNANCY AND LACTATION Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose. HEPATIC AND RENAL IMPAIRMENT Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m2). Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2. Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and Medication Guide. BA HCP ISI ALL 13JUN2022 About Olumiant Olumiant, a once-daily, oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. It is approved in the U.S. and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. FDA approval was granted for Olumiant for the treatment of certain hospitalized adult patients with COVD-19 in May 2022. Marketing authorization for Olumiant in COVID-19 has been granted in six other countries including Japan and Switzerland. The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis. See the full Prescribing Information here.4 In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of Olumiant and certain follow-on compounds for patients with inflammatory and autoimmune diseases. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Olumiant (baricitinib) as a treatment for alopecia areata and reflects Lilly's and Incyte's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, and that Olumiant will receive additional regulatory approvals, or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release. References: 1Passeron T, et al. Baricitinib provides significant hair regrowth in adolescents with severe alopecia areata: 36-week efficacy and safety results from a Phase 3 randomized, controlled trial. American Academy of Dermatology Annual Meeting. March 7-11, 2025. 2 Alopecia areata. National Alopecia Areata Foundation website. . Last accessed March 3, 2025. 3 King B, et al. Two Phase 3 trials for baricitinib in alopecia areata. N Engl J Med. 2022;386:1687-1699 DOI: 10.1056/NEJMoa2110343. 4 Olumiant. Prescribing Information. Lilly USA, LLC. SOURCE Eli Lilly and Company WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED