Upadacitinib hemihydrate

There are three oral JAK inhibitors on the market to treat alopecia areata. AbbVie has shown data for Rinvoq that shows it may be set up to become the fourth entrant in the indication. While the JAK inhibitor market for alopecia areata (AA) has grown increasingly crowded in recent years, Rinvoq’s clinical performance in the hair follicle-attacking autoimmune disease could earn AbbVie a prominent seat at the table.After 24 weeks of treatment, Rinvoq (upadacitinib) at two doses—15 mg and 30 mg—helped 44.6% and 54.3% of adult alopecia patients achieve 80% or more scalp hair coverage, respectively, in a phase 3 trial. That compared to just 3.4% of patients on placebo who achieved the same level of hair growth.Patients enrolled in the study entered at a baseline of roughly 16% scalp hair coverage, as determined by the severity of alopecia tool (SALT), AbbVie said in a July 30 press release.Meanwhile, across the same two Rinvoq doses, 36% and 47.1% of patients achieved 90% or more scalp hair coverage versus just 1.4% of patients in the trial’s control arm, AbbVie said.Rinvoq also met several secondary endpoints in the study by improving eyebrow and eyelash coverage and helping a certain percentage of patients on both doses achieve complete scalp hair coverage at the trial’s 24-week mark."Often misunderstood as a cosmetic issue, AA is a systemic immune-mediated disease that can cause total hair loss, involving the scalp, eyebrows and eyelashes," Kori Wallace, M.D., Ph.D., AbbVie's vice global head of immunology clinical development, said in a release. "UP-AA is the first pivotal program to have ranked and met the rigorous standard of SALT=0, indicating complete scalp hair regrowth."AbbVie did not indicate a regulatory plan for Rinvoq in the indication. The company is awaiting results from a parallel replicate study, which are expected later this quarter. While cross-trial comparisons are often problematic because of differences in timing, patient populations and other variables, Rinvoq appears to provide better results than three other JAK inhibitors currently on the market in the indication.The most recently approved treatment for alopecia, Sun Pharma’s Leqselvi, was tested on 1,220 patients in two trials with an average scalp coverage of 13%. At the 24-week mark, more than 30% of patients saw their scalp coverage increase to at least 80%.Eli Lilly’s Olumiant was approved in 2022 for alopecia based on trials that showed between 17% and 22% of patients taking a 2 mg daily dose achieve 80% scalp coverage after 36 weeks, while 32% to 35% of patients taking a 4 mg daily dose reached the same standard. Pfizer’s Litfulo was approved in 2023 after a study showed 23% of patients reached 80% or more of scalp coverage after six months of treatment.Last week, AbbVie reported Rinvoq’s second-quarter sales at $2.03 billion for a 42% year-over-year increase. The product generated $5.97 billion in revenue last year. The treatment hit the market in 2019 to treat patients with rheumatoid arthritis. Since then, it has been cleared in several other indications, including psoriatic arthritis, atopic dermatitis, Crohn’s disease and ulcerative colitis.

AbbVie is looking for business development opportunities which can fuel growth "in the next decade," CEO Rob Michael said. On a day when AbbVie revealed booming sales of Skyrizi and Rinvoq and another positive adjustment to its 2025 guidance, the company also is reportedly angling to bolster its long-term prospects by way of an acquisition, according to a Bloomberg report.The Illinois pharma is discussing a potential $1 billion deal to buy out New York City psychedelic drug specialist Gilgamesh Pharmaceuticals. The companies are already partners after AbbVie paid $65 million up front and pledged $1.95 billion in potential milestones last year to help develop candidates for major depressive disorder.While AbbVie didn’t specifically address the rumored deal during a conference call on Thursday, CEO Rob Michael did discuss in general how the company is thinking about business development.“When you look at the diverse, high-growth platform we have today, that’s really going to give us the opportunity to drive top-tier performance—a clear line of sight to growth—for at least the next eight years,” Michael said. “It’s really about how we set up the company to grow beyond Skyrizi and Rinvoq.”Michael added that the company will not lose patent protection for any of its significant growth drivers for the rest of this decade, which gives AbbVie the flexibility to invest more in R&D and to continue to acquire external innovation.Evidence of this philosophy is backed up by AbbVie’s recent acquisitions, including a $2.1 billion purchase a month ago of Capstan Therapeutics, which is developing in vivo CAR-T therapies for autoimmune and other disorders. In October, AbbVie spent $1.4 billion to acquire Aliada Therapeutics and its novel Alzheimer’s disease candidate.Gaining Aliada, added to a potential acquisition of Gilgamesh, bolsters AbbVie’s already healthy neuroscience portfolio. That business increased its sales by 24% in the second quarter as each of the company’s top four products “exceeded expectations,” according to AbbVie’s chief commercial officer, Jeff Stewart.“We are fully investing in neuroscience. We look forward to maintaining our leadership position there,” Stewart said. “We’re gonna keep feeding that engine.” The engine includes mood stabilizer Vraylar, which was up 16% to $900 million in sales; therapeutic Botox, which was up 14% to $928 million; migraine treatments Ubrelvy, which jumped 47% to $338 million; plus Qulipta, which saw an increase of 77% to $267 million.As for its immunology juggernauts, AbbVie reported sales of Skyrizi at $4.4 billion, which was a 62% increase year over year, while Rinvoq topped the $2 billion mark in quarterly sales for the first time, for a 42% increase.AbbVie jacked up its 2025 revenue guidance to $60.5 billion, which is an increase of $800 million from the company’s estimate three months ago. The company has increased its Skyrizi revenue projection by $600 million to $17.1 billion for the year, while decreasing its estimate for fading powerhouse Humira by $500 million to $3 billion for the year, “reflecting biosimilar competition,” CFO Scott Reents said. AbbVie did not adjust its 2027 projection of $31 billion for combined Skyrizi and Rinvoq sales, even though the products are tracking to exceed the figure. “We will update that at the appropriate time, but momentum is clearly there,” Michael said, adding that the company typically adjusts long-term guidance at the end of the year, often unveiling adjustments at the J.P. Morgan conference in January.As for its neuroscience portfolio, AbbVie has added $300 million, putting its projection for the year at $10.5 billion, which includes a $100 million increase for Parkinson’s disease drug Vyalev, which was approved in October of last year and generated $98 million in the second quarter, “reflecting strong international uptake,” Reents said.