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AbbVie Seeks Approval For SKYRIZI Based On Data From Three Phase 3 Studies

AbbVie (ABBV) has submitted an application to the FDA seeking approval for risankizumab-rzaa or SKYRIZI, for the treatment of patients 16 years and older with moderate to severe Crohn's disease. The submission is supported by data from three phase 3 studies - ADVANCE, MOTIVATE and FORTIFY.

Crohn's disease is a chronic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea, abdominal pain, and rectal bleeding.

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

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