FDA Approves AbbVie's SKYRIZI for Ulcerative Colitis

AbbVie has announced that the US Food and Drug Administration (FDA) has approved SKYRIZI (risankizumab-rzaa) for treating adult patients with moderately to severely active ulcerative colitis. SKYRIZI is notable for being the first IL-23 inhibitor approved for treating both moderate to severe ulcerative colitis and Crohn’s disease, extending its application within the field of inflammatory bowel disease (IBD).

The approved treatment regimen for SKYRIZI involves an induction period lasting 12 weeks, during which patients receive three doses of 1200mg each, administered every four weeks. Following this induction phase, maintenance therapy can continue with doses of either 180mg or 360mg every eight weeks. An added convenience for patients is the option to self-administer SKYRIZI at home using an on-body injector after the induction phase.

The FDA's approval is based on data from two pivotal Phase III clinical trials named INSPIRE and COMMAND, which evaluated SKYRIZI in patients with moderate to severe ulcerative colitis.

The INSPIRE trial was a randomized, multicenter, double-blind, placebo-controlled study. This trial assessed the safety and efficacy of a 1200mg intravenous dose of risankizumab, administered every four weeks as induction therapy for individuals with active ulcerative colitis. The COMMAND study, on the other hand, evaluated the safety and efficacy of risankizumab doses of 180mg or 360mg given subcutaneously in adults over a 52-week period as maintenance therapy for the same condition.

Both clinical trials achieved their primary endpoint, demonstrating clinical remission. They also reported significant endoscopic improvement, a critical secondary endpoint. These results underline the potential of SKYRIZI to effectively manage symptoms and improve the quality of life for patients with ulcerative colitis.

SKYRIZI, marketed by AbbVie, is the result of a collaboration with Boehringer Ingelheim. AbbVie holds the responsibility for the global commercialization and further development of this therapy. Roopal Thakkar, AbbVie's global therapeutics senior vice-president and chief medical officer, emphasized that the approval of SKYRIZI for ulcerative colitis enhances their portfolio for treating IBD and reflects their ongoing commitment to addressing patient needs.

Thakkar stated, “The approval of SKYRIZI for ulcerative colitis expands our IBD portfolio and demonstrates our commitment to helping address ongoing needs of patients. We will continue to invest in transforming the treatment landscape and the lives of people suffering from IBD.”

This latest advancement follows AbbVie's recent license agreement with FutureGen Biopharmaceutical to develop FG-M701 for IBD, further showcasing AbbVie’s dedication to expanding its therapeutic offerings and improving patient outcomes in the field of inflammatory bowel diseases.