European Commission approves Rinvoq for moderate to severe UC

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The European Commission has approved Rinvoq for the treatment of patients with moderate to severe ulcerative colitis who have had an inadequate response, lost response, or were intolerant to conventional treatment, according to a press release from AbbVie.

Approval of Rinvoq (upadacitinib, AbbVie) was based on results from three Phase 3 studies, in which the primary endpoint of clinical remission was achieved at week 8 in two induction studies (upadacitinib at 45 mg, U-ACHIEVE and U-ACCCOMPLISH) and at week 52 in the U-ACHIEVE maintenance study (15 mg and 30 mg). Rinvoq also induced secondary endpoints of clinical response and mucosal healing, with no significant new safety risks reported, the company said.

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“Our years of experience and long-term investments in inflammatory bowel disease research have given us invaluable insight into the challenges facing patients with ulcerative colitis and a deep understanding of the continued need for additional treatment options to help those still suffering,” Thomas Hudson, MD, senior vice president of research and development and chief scientific officer of AbbVie, said in the statement. “Today we celebrate the approval of Rinvoq by the [European Commission] as it greatly expands our ability to help indicated patients in need of ulcerative colitis relief.

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