European Commission Approves RINVOQ (upadacitinib) for the Treatment of Adults With Moderate to Severe Ulcerative Colitis

AbbVie announced the European Commission (EC) approved RINVOQ (upadacitinib 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

“Our years of experience and long-term investment in IBD research have given us invaluable insights into the challenges that ulcerative colitis patients face, and a deep understanding of the ongoing need for additional treatment options to help those still suffering,” said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. “We celebrate today’s approval of RINVOQ by the EC as it meaningfully expands our ability to help indicated patients in need of relief from ulcerative colitis.”

The EC approval is supported by data from two induction studies, U-ACHIEVE induction and U-ACCOMPLISH, and one maintenance study, U-ACHIEVE maintenance.2 Statistical significance was achieved for the primary endpoint and all secondary endpoints with RINVOQ 45 mg in the two induction studies and both RINVOQ 15 mg and 30 mg in the maintenance study.