AbbVie secures FDA approval for Skyrizi in ulcerative colitis

AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) for treating moderate-to-severe active ulcerative colitis (UC) in adults. This approval makes Skyrizi the first IL-23-specific inhibitor authorized for both UC and Crohn’s disease (CD) in the United States. Roopal Thakkar, Chief Medical Officer of Global Therapeutics at AbbVie, stated that this approval broadens their inflammatory bowel disease (IBD) portfolio, addressing the ongoing needs of patients with UC.

The FDA's approval of Skyrizi for UC is supported by data from two late-stage clinical trials: the 12-week induction study named INSPIRE and the 52-week maintenance study called COMMAND. Both studies achieved their primary goal of clinical remission and secondary endpoint of endoscopic improvement.

For UC, Skyrizi's treatment regimen involves an initial 12-week induction period where patients receive three 1200mg doses administered every four weeks. This is followed by a maintenance phase with either 180mg or 360mg doses every eight weeks, which can be administered at home using an on-body injector.

This recent approval adds to Skyrizi’s indications in the United States, making it the fourth approved indication for the drug across immune-mediated inflammatory diseases. Originally approved in 2019 for moderate-to-severe plaque psoriasis, Skyrizi's label was expanded in 2022 to include active psoriatic arthritis. By June 2022, the FDA had also approved it for treating moderate-to-severe active CD, based on favorable outcomes from the late-stage ADVANCE and MOTIVATE induction trials.

Skyrizi, developed in collaboration with Boehringer Ingelheim, is awaiting approval in the European Union as a potential treatment for UC, having already received a positive opinion from the European drug advisory panel last month. The biologic generated nearly $2.4 billion in global sales last year.

In addition to Skyrizi, AbbVie’s UC treatment portfolio includes Rinvoq (upadacitinib), which received FDA approval in 2022. AbbVie is actively working to bolster its presence in the IBD market. Recently, they entered into a licensing agreement potentially worth $1.7 billion with China's FutureGen Biopharmaceutical to develop a next-generation anti-TL1A antibody.

The UC treatment landscape has seen recent additions with the approval of Pfizer’s Velsipity (etrasimod) and Lilly’s Omvoh (mirikizumab-mrkz) in the United States in October of the previous year.