Upadacitinib

With its latest approval, Skyrizi is now approved to treat both of the forms of inflammatory bowel disease. AbbVie’s fast-growing Humira successor Skyrizi is already on a roll with skyrocketing sales. Now, the IL-23 inhibitor is poised to take on an even larger share of Humira’s fading market dominance with a key expansion into ulcerative colitis. On Tuesday, the FDA granted Skyrizi approval to treat adult patents with moderately to severely active ulcerative colitis (UC). The approval adds some 1 million U.S. patients to the drug’s reach and makes Skyrizi the first IL-23 inhibitor cleared to treat both UC and Crohn’s, the two forms of inflammatory bowel disease (IBD).  Following a 12-week induction period, patients can dose themselves at home with an on-body injector device “designed with patients in mind," according to AbbVie's press release. The device adheres to the body and delivers the med in about five minutes. Even in a crowded disease area, Skyrizi boasts an edge with prescribers. A Spherix Global Insights poll of 101 gastroenterologists found that doctors are already on board with the med as a UC treatment, with one-third reporting that Skyrizi is a significant advance over existing products. Doctors favor AbbVie’s offering over Johnson & Johnson’s Tremfya and Abivax’s obefazimod, and most are highly familiar with the drug. One gastroenterologist said they prefer Skyrizi because it has “the best efficacy profile among the IL-23 agents.” After its Crohn's approval in 2022, Skyrizi has been a formidable IBD rival to Johnson & Johnson’s blockbuster Stelara. The AbbVie drug has been taking a “significant share” of the J&J med’s sales, AbbVie executives said on an April earnings call. Coupled with its other two approvals in psoriatic arthritis and plaque psoriasis, AbbVie is making strides in its plan to build up Skyrizi—as well as JAK inhibitor Rinvoq—to make up for falling Humira sales. Last year, Skyrizi’s sales reached $7.7 billion, a 50% leap over 2022.  The company has long been working on the double threat to buoy its immunology profile as once-king Humira falls to biosimilar competition following its loss of exclusivity in 2023. With the still-rising success of the two drugs, it’s looking like the plan might be coming to fruition even better than AbbVie once hoped. Analysts at GlobalData expect Skyrizi sales to peak in 2030 at $19.7 billion, while Rinvoq should peak at $12.3 billion for a total haul of $32 billion. By the end of the decade, the duo is poised to contribute 42% of AbbVie’s total revenue. “Given their 2030 drug expiries, these drugs are estimated to not only bolster sales for an extended period of time but […] are [also] poised for long-term sales growth, enabling the company to not only financially recover from Humira’s expiry but to also continue its position as a formidable player within the immunology therapy area,” GlobalData pharma analyst Jasper Morley said in the report.

AbbVie announced Tuesday that the FDA approved Skyrizi (risankizumab-rzaa) for the treatment of moderate-to-severe active ulcerative colitis (UC) in adults, making it the first IL-23-specific inhibitor cleared for both UC and Crohn’s disease (CD) in the US. “Today's approval…expands our IBD [inflammatory bowel disease] portfolio…helping address ongoing needs of patients” with UC, remarked Roopal Thakkar, chief medical officer of global therapeutics at AbbVie. The approval was backed by results from two late-stage studies – the 12-week induction study INSPIRE and the 52-week maintenance study COMMAND, both of which met the main goal of clinical remission, alongside the secondary endpoint of endoscopic improvement.AbbVie noted that Skyrizi’s dosing for this indication involves a 12-week induction period with three 1200mg doses every four weeks, followed by a maintenance regimen of either 180mg or 360mg every eight weeks that can be administered at home using an on-body injector.The approval marks the fourth indication for Skyrizi in the US across immune-mediated inflammatory diseases. Its first approval came through in 2019 for moderate-to-severe plaque psoriasis, with a subsequent label expansion in 2022 for active psoriatic arthritis. In June 2022, the FDA cleared the IL-23 inhibitor for the treatment of moderate-to-severe active CD, based on positive findings from the late-stage ADVANCE and MOTIVATE induction trials. Skyrizi, which is partnered with Boehringer Ingelheim,  is also awaiting approval in the EU as a potential  treatment for UC, after securing a positive opinion by the European drug advisory panel last month. The biologic made nearly $2.4 billion in global sales last year.AbbVie’s portfolio of targeted therapies for UC also includes Rinvoq (upadacitinib), which was cleared by the FDA in 2022. The drugmaker is looking to strengthen its foothold in IBD through a recent licensing deal potentially worth $1.7 billion with China's FutureGen Biopharmaceutical to develop a next-generation anti-TL1A antibody. Other recent entrants in the UC arena include Pfizer’s Velsipity (etrasimod) and Lilly’s Omvoh (mirikizumab-mrkz), both approved in the US in October last year.