EarLy Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT): a Parallel Group, Randomized, Double Blind, Placebo Controlled Trial

Most individuals with mild traumatic brain injury (mTBI) experience post-traumatic headaches (PTH). Of PTH, 50% present with a migraine phenotype which is the most disabling type of PTH. Patients with migraine-PTH are at greater risk of persistent symptoms whereby the acute PTH (aPTH) becomes persistent PTH (pPTH) (ie. lasting > 3 months) with a conversion rate of 47-95%. As migraine symptoms become chronic, it becomes treatment resistant. Despite these implications, early preventive medication management of PTH is marred by lengthy trials of multiple medications (2-3 months for each) and adverse effects that aggravate mTBI symptoms (fatigue, nausea, and presyncope). There is a compelling need to establish an effective treatment to prevent this debilitating outcome. Eptinezumab is a calcitonin gene-related peptide (CGRP)-blocking monoclonal antibody that reduces migraine burden in patients with migraines after a single infusion. Patients with PTH have higher serum levels of CGRP and experimental infusion of CGRP to patients with mTBI reproduces migraine PTH symptoms. Given the similarly in CGRP expression between chronic migraines and PTH, an infusion of eptinezumab within 8 weeks of PTH is hypothesized to reduce headache burden 3 months after treatment and prevent pPTH.

Start Date01 Oct 2025

Sponsor / Collaborator

Sunnybrook Health Sciences Centre

NCT07035197

/ RecruitingNot ApplicableIIT

Facilitators and Barriers to Eptinezumab Administration in Thailand: Real-World Experiences and Perspectives From Mixed-method Design and In-Depth Interviews (FACEpi)

This research study is designed as a longitudinal prospective descriptive study using mixed-method data collection. Eptinezumab, an anti-calcitonin gene-related peptide monoclonal antibody (anti-CGRP mAb), is administered by intravenous (IV) infusion every 3 months as preventive medication for individuals with migraine who have been diagnosed based on theInternational Classification of Headache Disorders, 3rd edition (ICHD-3) by headache specialist neurologists. The goal of this study is to understand the real-life experiences of people with migraine who receive eptinezumab in a hospital setting in Thailand, a middle-income country. The researchers want to learn about what makes it easier or harder for patients and healthcare workers to use this treatment.
The main questions it aims to answer are:
* What are the barriers and facilitators to using eptinezumab from the perspectives of patients and healthcare providers?
* Does eptinezumab reduce monthly migraine days and improve quality of life over time?
Participants will:
* (For migraine patients) Take part in an in-depth interview (IDI) within 24 hours after receiving an eptinezumab infusion
* (For migraine patients) Complete questionnaires about migraine symptoms, disability, and quality of life at baseline, 3 months, and 6 months
* (For healthcare providers) Take part in a one-time interview about their experiences administering eptinezumab
The study will also look at how well eptinezumab works by measuring changes in monthly migraine days and other health scores over a 6-month period. The information from this study may help improve migraine care in Thailand and support better access to new treatments like eptinezumab.

Start Date25 Aug 2025

Sponsor / Collaborator

H. Lundbeck A/S

NCT05937152

/ WithdrawnPhase 2IIT

CAT-Trial: CGRP Monoclonal Antibody for Treatment of Painful Diabetic Neuropathy: a Double-blind, Randomized, Placebo-controlled, International Multicenter, Phase II Clinical Trial

The main purpose of this study is to compare the change in pain intensity during treatment with a CGRP monoclonal antibody (eptinezumab) compared with placebo treatment in patients with painful diabetic polyneuropathy (DPN).

Start Date01 Jan 2025

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Eptinezumab-JJMR

100 Translational Medicine associated with Eptinezumab-JJMR

100 Patents (Medical) associated with Eptinezumab-JJMR

230

Literatures (Medical) associated with Eptinezumab-JJMR

02 Sep 2025·PREPARATIVE BIOCHEMISTRY & BIOTECHNOLOGY

Heavy chain variants affect light and heavy chains assembly of monoclonal antibody expressed by Pichia pastoris

Article

Author: Ye, Kaixiong ; Cai, Menghao ; Xu, Mingqiang ; Zhou, Xiangshan ; Liu, Qi ; Liu, Haifeng ; Gong, Xiulong ; Qian, Zhilan ; Wang, Xiaolong

Monoclonal Antibody accounts for the largest share of recombinant protein drugs and is the primary choice for the treatment of various diseases. In this study, the monoclonal antibody Eptinezumab was expressed by a yeast host Pichia pastoris. Although the expression and secretion of light chain was efficient, the assembly efficiency between light and heavy chains was low. As the retention of the heavy chain in endoplasmic reticulum may trigger protein degradation, ERAD ubiquitination-related genes were then knocked out separately but it only led to minor improvement effect. Expression of splitted heavy chain variants further revealed that although endoplasmic reticulum retention of the heavy chain upregulated KAR2 expression, it did not affect the assembly efficiency of the light and heavy chains. It was inferred that binding of complete heavy chains to KAR2 spatially affected the assembly between light and heavy chains. Design and screening of KAR2 variants that facilitating full-length antibody assembly could be preferentially considered in future.

01 Sep 2025·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Ubrogepant, erenumab, and eptinezumab antagonize positive inotropic effects of the calcitonin gene–related peptide in the isolated human atrium

Article

Author: Gergs, Ulrich ; Neumann, Joachim ; Hofmann, Britt

Abstract:

The calcitonin gene–related peptide (CGRP) is an endogenous peptide that is known to be involved in the development of a migraine. CGRP is also present in the human heart, acts via CGRP receptors, and has been shown to increase the force of contraction (FOC) in isolated, electrically driven human atrial preparations (HAP) from adult patients obtained during open-heart surgery. Here, the hypothesis was tested that the positive inotropic effect (PIE) of CGRP could be attenuated by three anti-migraine drugs, namely ubrogepant, erenumab (both CGRP receptor antagonists), and eptinezumab (a CGRP antagonist). CGRP, cumulatively applied at concentrations ranging from 1 to 100 nM, increased the FOC. In the presence of cilostamide, an inhibitor of phosphodiesterase III, CGRP was more potent and effective than in the absence of cilostamide. Furthermore, when 100 nM CGRP was administered, subsequent application of ubrogepant (1 nM), erenumab (2 nM), and eptinezumab (6 nM) led to a reduction of FOC in HAP. In a more effective way, 1 µM carbachol and 1 µM (-)-N6-phenylisopropyladenosine (PIA) attenuated the PIE of CGRP in the presence of cilostamide. Conversely, when we applied first ubrogepant (1 nM), erenumab (2 nM), or eptinezumab (6 nM), then, this pre-incubation attenuated the PIE in HAP of cumulatively applied CGRP compared to CGRP given alone. We conclude that ubrogepant, erenumab, and eptinezumab are functional antagonists of CGRP in HAP at therapeutic concentrations of these anti-migraine drugs. Further investigation is necessary to determine whether this reduction in FOC is beneficial or detrimental for migraine patients.

03 Aug 2025·Pain Management

Eptinezumab for migraine prevention after other treatments fail: a plain language summary of publications

Article

Author: Ettrup, Anders ; Ashina, Messoud ; Boserup, Line Pickering ; de la Torre, Elena Ruiz ; Starling, Amaal J.

News (Medical) associated with Eptinezumab-JJMR

11 Sep 2025

·www.prnewswire.com

Lundbeck showcases new clinical migraine data, including long-term preventive effectiveness of Vyepti® (eptinezumab) in patients severely impacted by migraine

Lundbeck demonstrates leadership and unwavering commitment to advancing migraine management and supporting patient outcomes with six presentations at the 2025 International Headache Congress (IHC), including three oral presentations on eptinezumab (Vypeti®) and Lu AG09222 (anti-PACAP mAb) New data from the open-label extension of the RESOLUTION trial and the primary results of the SUNSET extension trial will be presented for the first time at IHC1,2 Patients treated with eptinezumab experienced sustained reductions in migraine symptom and burden, including long-term reduction in monthly migraine days (MMDs) and improvements in patient-reported outcomes1,2 VALBY, Denmark, Sept. 11, 2025 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) is advancing leadership in migraine with a comprehensive collection of datasets to be presented at the 2025 International Headache Congress, taking place in São Paulo (Sept 10-13).1-6 Among data presented, Lundbeck will announce the full results of the 12-week, open-label extension of the RESOLUTION trial investigating eptinezumab for the prevention of migraine in patients with chronic migraine and associated medication overuse headache (MOH) who also received standardized patient education.1 In addition, new data from the SUNSET open-label extension trial in Japanese patients with chronic migraine will be shared with the scientific community for the first time.2 "Migraine is a chronic, disabling disease that disrupts lives and demands a comprehensive, long-term management approach," said Johan Luthman, EVP, and Head of Research & Development at Lundbeck. "Patients deserve preventive treatments that not only deliver early relief but sustain their impact over time. The RESOLUTION and SUNSET trials show that patients who experience an early, clinically significant response with eptinezumab continue to maintain this response long-term. This offers renewed hope for those severely impacted by the burden of migraine." In the phase 4 RESOLUTION trial,7 the early, clinically meaningful improvements in migraine symptom and burden observed during the initial placebo-controlled period were sustained during the open-label extension period. Around 50% of patients achieved a ≥50% reduction from baseline in monthly migraine days (MMDs) and achieved approximately nine days fewer MMDs at the end of the 12 week OLE, compared to baseline at the start of the RESOLUTION trial (baseline was 20.9 MMDs).1 Additionally, the primary results of the SUNSET trial will be presented at IHC. SUNSET was a 60-week open-label extension of the Asian registrational SUNRISE trial, designed to evaluate the long-term safety, tolerability and efficacy of eptinezumab in a Japanese population with chronic migraine.2 In the trial the symptom reduction observed within the first 12 weeks of treatment with eptinezumab (SUNRISE trial) was maintained across the open-label period.2 The proportion of participants with a ≥50% or ≥75% MMD reduction from baseline was sustained throughout the trial, with 35.7% of patients achieving a 50% reduction in MMD by week 49-60. A trend towards increasing ≥75% response rate was also observed across the 60-weeks extension period.2 Eptinezumab was well tolerated across both trials,1,2 similar to previous trials in migraine prevention and to the current labelled safety information in the United States prescribing information and the EU Summary of Product Characteristics. These data collectively underscore the long-term effectiveness, tolerability, and safety of eptinezumab in addressing the needs of patients severely impacted by migraine, and underscores Lundbeck's commitment to lifting the burden of migraine for patients globally. Details of Lundbeck's scientific program at IHC: Satellite symposium Revolutionizing patient care through science: From neuropeptides to higher standards in migraine prevention. Speakers: Peter J. Goadsby, Gisela Terwindt and Stewart Tepper, Saturday 13 September: 13:00-14:30 Oral presentations Efficacy and safety of eptinezumab in adults with chronic migraine and medication-overuse headache: 24-week results of the RESOLUTION trial. Presented by Henrik W Schytz. Saturday 13 September: 16:00-17:001 Eptinezumab improved patient-reported disease burden and quality of life in a predominantly Asian population with chronic migraine: Secondary results from the SUNRISE trial. Presented by Patricia Pozo-Rosich. Saturday 13 September: 10:30-11:303 Patient perspectives of migraine symptomology: Insights from exit interviews from the anti-PACAP antibody Phase 2 HOPE trial for migraine prevention. Presented by Richard Lipton. Saturday 13 September: 10:30–11:30.4 ePoster presentations Eptinezumab reduced disease burden in chronic migraine and medication-overuse headache in patients also receiving patient education: Results from the placebo-controlled RESOLUTION trial. Tepper SJ, et al. Saturday 13th September5 Efficacy and safety of eptinezumab in chronic migraine: Randomized controlled trial in a predominantly Asian population. Yu S, et al. Friday 12th September6 Long-term tolerability and effectiveness of eptinezumab in Japanese adults with chronic migraine: The 60-week, open-label SUNSET trial. Takeshima T, et al. Saturday 13th September2 About migraine and medication-overuse headache (MOH) Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound.8 Migraine is the second leading cause of years lived with disability (YLD) among all diseases, and it is the top YLD cause among patients aged 15 to 49 years, according to the Global Burden of Disease study.9 As the most prevalent neurological disorder in people aged <50 years, migraine imposes both a social and financial burden. In Europe, migraine alone affects close to 50 million people costing the economy EUR 18 billion annually according to the Cost of Brain Disorders in Europe10 study and this is without the indirect cost associated with presenteeism (i.e. productivity losses due to reduced efficiency of persons who are not sufficiently ill to be absent from work). Repeated migraine attacks, and often the constant fear of the next one, damage family life, social life, and work life. Furthermore, increased use of acute headache medications may lead to central sensitization and decreased effectiveness of the acute headache medication, resulting in a cycle of increased number of headache days requiring even further increased amounts of acute headache medication. Without proper migraine management, this process results in worsening migraine and may lead to the development of chronic migraine and MOH.11 The secondary headache of MOH is a common complication among individuals with primary headache disorders like chronic migraine. About the RESOLUTION trial RESOLUTION was a phase 4, randomized, placebo-controlled trial designed to evaluate the efficacy of eptinezumab versus placebo in patients with chronic migraine and associated medication-overuse headache (MOH) who also received standardized patient education.7 RESOLUTION included a 12-week double-blind, placebo-controlled period followed by a 12-week open-label extension. The participants in the RESOLUTION trial were mainly from European countries. RESOLUTION is the first randomized controlled trial to assess the efficacy of an anti-CGRP treatment in combination with structured patient education in chronic migraine and MOH. The trial enrolled 608 participants with dual diagnoses of chronic migraine and MOH, and participants were randomly allocated to one of two treatment groups, brief educational intervention (BEI) and eptinezumab (100 mg; n = 305) or BEI and placebo (n = 303), in a 1:1 ratio. BEI involves a short screening followed by individual feedback on how and why acute migraine medication use should be reduced, and this approach to patient education has been shown to result in long-term medication reductions for patients with MOH. At the end of Week 12, 584 participants continued in the 12-week, open-label extension, where all participants received eptinezumab 100 mg. Clinical efficacy endpoints included change from baseline in MMDs, ≥50% and ≥75% responder rate and change from baseline in monthly days with acute medication use. Key secondary endpoints included reductions in headache-related burden, migraine-related disability, work productivity loss, activity impairment, and the safety and tolerability of eptinezumab in this patient population. About the SUNSET trial The SUNSET trial (NCT05064371) was an extension of the phase 3, multiregional, randomized, double-blind, placebo-controlled SUNRISE trial (NCT04921384) conducted in adults (18–75 years) diagnosed with chronic migraine.2 159 Japanese participants who completed SUNRISE were enrolled and treated in SUNSET after completing 12-week, randomized, double-blind treatment with IV eptinezumab 100 mg, 300 mg, or placebo. SUNSET comprised a 60-week open-label treatment period (during which participants received IV eptinezumab every 12 weeks [5 doses total] and completed a daily electronic diary) and an 8-week safety follow-up period. All participants received eptinezumab 100 mg at baseline in SUNSET, participants who did not achieve ≥50% reduction from SUNRISE baseline in monthly migraine days (MMDs; SUNSET Weeks 1–12) had their dose increased to 300 mg at SUNSET Week 12 and onward. The primary endpoints investigated long-term safety and tolerability, including treatment emergent adverse events (TEAEs). Secondary endpoints included change from baseline in the number of MMDs, ≥50% and ≥75% migraine responder rates (MRRs), and Patient Global Impression of Change (PGIC) score. Exploratory endpoints included change from baseline in the Migraine-specific Work Productivity and Activity Impairment (WPAI:M) questionnaire domain scores. About Vyepti® (eptinezumab) Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was intentionally designed for IV administration. The efficacy and safety of eptinezumab was evaluated in two phase III clinical trials (PROMISE-1 in episodic migraine12 and PROMISE-2 in chronic migraine13), where eptinezumab met its primary endpoint of decrease in MMDs over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of eptinezumab as early as Day 1 post-infusion. The safety of eptinezumab was evaluated in more than 2,000 adult patients with migraine who received at least one dose of eptinezumab. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with eptinezumab discontinued treatment due to adverse reactions. VYEPTI (eptinezumab-jjmr) was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Commission (EC) for the prophylaxis of migraine in adults who have at least four migraine days per month. Today, eptinezumab is launched in more than 30 markets worldwide. Contacts Marie Petterson Jens Høyer Head of Media Relations, Corp. Communication Vice President, Head of Investor Relations [email protected] [email protected] +45 29 82 21 82 +45 30 83 45 01 About H. Lundbeck A/S Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. Lundbeck has approximately 5,700 employees in more than 50 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site and connect with us via LinkedIn. References: 1. Jensen RH et al. Oral presentation at IHC 2025 2. Takeshima T et al. ePresentation at IHC 2025 3. Yu S et al. Oral presentation at IHC 2025 4. Lipton RB et al. Oral presentation at IHC 2025 5. Tepper SJ et al. ePresentation at IHC 2025 6. Yu S et al. ePresentation at IHC 2025 7. Jensen RH, et al. Front. Neurol. 2023; 14:1114654 8. Villalón CM. Pharmacol Ther. 2009;124(3):309-323 9. Steiner TJ, et al. J Headache Pain. 2018;19(1):17 10. Gustavsson A, et al. Eur Neuropsychopharmacol. 2011;21(10):718-79 11. Lipton RB, et al. J Neurol. 2023; 270, 5692–5710 12. Ashina M, et al. Cephalalgia. 2020;40(3):241-254 13. Lipton RB, et al. Neurology. 2020;94(13):e1365-e1377 CONTACT: H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Denmark +45 3630 1311 [email protected] This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug ApprovalPhase 2

29 Aug 2025

·www.einpresswire.com

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

15 Aug 2025

·www.fiercepharma.com

Lundbeck dials up migraine drug's US peak sales estimate, stays positive on Rexulti's PTSD use

Lundbeck is undergoing a sweeping capital reallocation initiative to channel resources to strategic brands such as Vyepti and Rexulti, plus key R&D projects. After a 54% year-over-year sales increase for CGRP migraine drug Vyepti in the U.S., Lundbeck has raised its peak sales projection for the therapy in the key market.The Danish company now expects the CGRP blocker to reach more than $1.1 billion in sales at peak in the U.S., a $100 million increase from its previous guidance. In the second quarter, Vyepti’s sales were 1.83 billion Danish kroner ($287 million) in the States, representing 87% of the drug's global total.Vyepti is the only infused CGRP med in a drug class filled with oral pills and under-the-skin injectables. Approved by the FDA in 2020 to prevent migraine episodes, Vyepti was the fastest-growing anti-CGRP agent in the U.S. as of June, with its demand growth of 50% year over year versus 20% for the overall market, according to Lundbeck.To fuel Vyepti’s growth, Lundbeck has invested in healthcare provider engagement, patient activation and patient support services, Tom Gibbs, head of Lundbeck’s U.S. operations, said in an investor call Thursday.“We continue to see accelerating demand by driving depth and breadth of prescribing of Vyepti and continued positive momentum in new patient starts supported by a high written-to-infusion conversion ratio and best-in-class patient persistency,” Gibbs said.Vyepti’s rollout has benefited from a sweeping capital reallocation initiative launched after Lundbeck’s current CEO Charl van Zyl joined in 2023. The goal is to channel resources to strategic brands such as Vyepti and the antipsychotic Rexulti, plus key R&D projects. Toward that end, Lundbeck last year transferred U.S. rights and promotion responsibility around the depression drug Trintellix to its partner Takeda.The company now expects to redeploy about 1.3 billion Danish kroner to 1.5 billion kroner by 2027, an increase from a previous range between 1 billion kroner to 1.3 billion kroner, thanks in part to changes in Lundbeck’s commercial model as a result of the Trintellix divestiture, CFO Joerg Hornstein said on the call. Besides Vyepti, Otsuka-partnered Rexulti also delivered strong sales growth for Lundbeck, at 28% worldwide, to reach revenue of 3 billion kroner in the second quarter. The increase has been driven by demand for the treatment of Alzheimer’s disease agitation.But Rexulti recently suffered a setback as an FDA advisory committee cast an overwhelmingly negative vote, saying that the efficacy of the drug’s proposed use alongside sertraline in post-traumatic stress disorder (PTSD) has not been established by existing clinical data.The problem stemmed from one of two phase 3 trials of Rexulti in the indication missing statistical significance. Still, the near-unanimous thumbs-down came as a bit of a surprise given that several panel members suggested that combo may be effective. Lundbeck’s R&D chief, Johan Luthman, apparently picked up on the positive sentiment despite the negative vote.“I think this is an interesting sentiment because we have good data, but not what you regularly like to see for an approval in this space,” he said, referring to the FDA’s typical requirement to have two positive phase 3 trials to grant an antipsychotic approval.There’s a high medical need in PTSD as the last FDA approval in the field was 23 years ago, Luthman noted on Thursday’s call.Several advisory committee members suggested that they would be willing to use the Rexulti regimen off-label in patients who do not respond to sertraline, one analyst recalled on the Lundbeck conference call.Gibbs noted that Rexulti enjoys very good payer access on both the commercial side and on Medicare, and that payer management of utilization doesn’t really get to the indication level. In addition to Alzheimer’s agitation, the drug is currently also approved for major depressive disorder and schizophrenia.Thanks to strong performance from Vyepti and Rexulti, Lundbeck again raised its full-year growth expectations to a range between 11% to 13% at constant currencies, versus the prior projection of 8% to 11% growth. For the first half of the year, Lundbeck’s total revenue jumped 14% to 12.3 billion kroner ($1.9 billion).

Drug ApprovalPhase 3BiosimilarClinical ResultFinancial Statement

100 Deals associated with Eptinezumab-JJMR

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KEGG	Wiki	ATC	Drug Bank
-	Eptinezumab-JJMR	L01XC	DB14040

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	United States	Lundbeck Seattle BioPharmaceuticals, Inc.	21 Feb 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Headache caused by drug	Phase 3	United States	H. Lundbeck A/S	17 Feb 2021
Headache caused by drug	Phase 3	South Korea	H. Lundbeck A/S	17 Feb 2021
Headache caused by drug	Phase 3	Spain	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	United States	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	China	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	Georgia	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	Spain	H. Lundbeck A/S	17 Feb 2021
Headache Disorders, Secondary	Phase 3	Taiwan Province	H. Lundbeck A/S	17 Feb 2021
Cluster Headache	Phase 3	United States	H. Lundbeck A/S	23 Dec 2020
Cluster Headache	Phase 3	Japan	H. Lundbeck A/S	23 Dec 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04688775 (ALLEVIATE, Pubmed \| JAMA Neurol)	Phase 3	Cluster Headache	231	Eptinezumab 400 mg	xmkwhldgud(fpwkwhehbc) = zwbdokqcek ypbjjdgcml (gtzdrgdhjq )	Positive	01 Jul 2025
				Placebo	xmkwhldgud(fpwkwhehbc) = nllrwtuojz ypbjjdgcml (gtzdrgdhjq )
AAN2025	Phase 3	Migraine Disorders	128	Eptinezumab 300 mg	wlyrwhdlfo(ntfncxszrt) = abyuzfkczq vzamsxlwqt (tmuklcydin ) View more	Positive	07 Apr 2025
P12-12.010 (AAN2025)	Not Applicable	Migraine Disorders	94	Eptinezumab (≥75% increase in good days/month)	duztgmibys(hwjupdmhpb) = eoozctcjpe stikvzonfb (tknyegzapm )	Positive	07 Apr 2025
				Eptinezumab (<75% increase in good days/month)	duztgmibys(hwjupdmhpb) = faaryssfmx stikvzonfb (tknyegzapm )
AAN2025	Phase 3	Migraine Disorders Maintenance	858	Eptinezumab 100 mg	ebayrorajr(kjcyilgdve) = bczdfafyde czinxpbppt (fkxvrvlyld ) View more	Positive	07 Apr 2025
				Eptinezumab 300 mg	ebayrorajr(kjcyilgdve) = ygrduxjyjg czinxpbppt (fkxvrvlyld ) View more
NCT02974153 (PROMISE-2, Pubmed \| J Neurol)	Phase 3	Migraine Disorders \| Headache	1,072	Eptinezumab	uxhzxrvzcq(hacapgqusr) = npffbjhrge dggjtuljcr (taphmpfhsv ) View more	-	01 Jan 2025
				Placebo	uxhzxrvzcq(hacapgqusr) = oxgoalkfvn dggjtuljcr (taphmpfhsv ) View more
NCT04249427 (CTgov)	Phase 4	Rhinitis, Allergic \| Facial Pain	29	Erenumab Prefilled Syringe (Erenumab)	spofxtjmow(shqhlpjkrk) = fpfsycnjns sqqcwhpovu (wbyeufnrqw, 6.9) View more	-	24 Sep 2024
				Placebo (Placebo)	spofxtjmow(shqhlpjkrk) = ivjunaokqn sqqcwhpovu (wbyeufnrqw, 8.0) View more
NCT04688775 (ALLEVIATE, CTgov)	Phase 3	Cluster Headache	231	Eptinezumab (Eptinezumab)	rkjtduneck(rvxjeqytlb) = ifyfyjvzfh zlwbifmsby (exaxfjggol, 0.93) View more	-	09 Aug 2024
				placebo+eptinezumab (Placebo)	rkjtduneck(rvxjeqytlb) = dicswyxgdf zlwbifmsby (exaxfjggol, 0.89) View more
NCT05064397 (CHRONICLE, CTgov)	Phase 3	Cluster Headache	131	Eptinezumab	fsohamghrc = zwlmoywpqb ruhjatyrjf (ilmqnswcux, vafxoonzky - nmjisckiqn) View more	-	06 Aug 2024
EAN2024	Not Applicable	Migraine Disorders	-	Eptinezumab	qgppjmvmsb(jdhbnitiai) = Mild side effects occurred in 6% of patients, including two cases of mild hypersensitivity reactions jykrkoiuiu (oowdjsnzae )	-	28 Jun 2024
REVIEW (AAN2024)	Not Applicable	Migraine Disorders	94	Eptinezumab (Patients with psychiatric conditions)	skcuaocrcd(hdggzcegje) = jypmtgmbpg pfuzpaxycm (txnbtsomxm ) View more	Positive	09 Apr 2024
				Eptinezumab (Patients without psychiatric conditions)	skcuaocrcd(hdggzcegje) = bsbjtlqhkm pfuzpaxycm (txnbtsomxm ) View more

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