US-based biopharmaceutical firm AbbVie (NYSE: ABBV) announced on Monday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (RINVOQ(R), 45mg [induction dose] and 15mg and 30mg [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

AbbVie's application for the approval of upadacitinib in UC is supported by data from two induction studies, U-ACHIEVE induction and U-ACCOMPLISH, and one maintenance study, U-ACHIEVE maintenance. Across all three Phase 3 studies, significantly more patients treated with upadacitinib achieved the primary endpoint of clinical remission(+) and all secondary endpoints. This includes statistically significant improvements in these endpoints compared to placebo with 45mg once daily for the induction studies, and with both 15mg and 30mg once-daily doses for the maintenance study. Additionally, safety results of upadacitinib in UC were consistent with the known safety profile of upadacitinib in rheumatoid arthritis, with no new important safety risks observed.

'As leaders in the advancement of care for people with inflammatory bowel disease, we are committed to continued research and development of treatment options that go beyond managing symptoms and include endoscopic and histologic outcomes,' said Neil Gallagher, M.D., Ph.D., vice president, development, chief medical officer, AbbVie. 'With today's CHMP recommendation of upadacitinib in ulcerative colitis, we've taken a giant step forward toward helping more patients achieve their treatment goals.'