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

NORTH CHICAGO, Ill., Sept. 20, 2021 /PRNewswire/ — 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.


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