AbbVie (ABBV) Submits Regulatory Applications to FDA and EMA for Upadacitinib in Crohn's Disease

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AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Crohn's Disease

July 27, 2022 8:45 AM EDT

Submissions are supported by three Phase 3 clinical trials demonstrating upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response as induction and maintenance treatment1-4Safety results were generally consistent with the known safety profile of upadacitinib, with no new safety risks observed1-8Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain9,10

NORTH CHICAGO, Ill., July 27, 2022 /PRNewswire/ --... More