AbbVie bags expanded FDA nod for Skyrizi in ulcerative colitis

2024-06-19

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 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.

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