AbbVie (ABBV) Submits Regulatory Application to FDA for Risankizumab-rzaa for Treatment of Patients 16 Years and Older with Moderate to Severe Crohn's Disease

AbbVie (NYSE: ABBV) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for risankizumab-rzaa (600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate to severe Crohn's disease. The submission is supported by safety and efficacy data from three Phase 3 studies – ADVANCE, MOTIVATE and FORTIFY.

"While there have been advancements in care, many people with Crohn's disease do not achieve lasting remission," said Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie. "This submission is an important step forward in our commitment to providing an additional treatment option for those who struggle with this debilitating and often unpredictable disease."

In the analysis plans for the U.S. submission of the ADVANCE and MOTIVATE induction studies, a significantly greater proportion of patients with Crohn's disease treated with either dose of risankizumab-rzaa IV induction therapy (600 mg or 1200 mg) met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo.1,2

In the analysis plans for the U.S. submission of the FORTIFY trial, a randomized-withdrawal maintenance trial of patients with clinical response to risankizumab-rzaa induction therapy, a significantly greater proportion of participants achieved the co-primary endpoints of endoscopic response and clinical remission with risankizumab-rzaa SC maintenance therapy at one year (52 weeks) for both assessed doses (360 mg or 180 mg), compared to those who were randomized to the withdrawal arm and received placebo SC (control group).3

The safety profile of all tested doses of risankizumab-rzaa in moderate to severe Crohn's disease in the ADVANCE, MOTIVATE and FORTIFY studies was generally consistent with the known safety profile of risankizumab-rzaa.1-7

SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

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