CHMPrecommends Rinvoq for the treatment of adult patients with moderately to severely active ulcerative colitis .- AbbVie

AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (Rinvoq, 45 mg [induction dose] and 15 mg and 30 mg [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 III 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 45 mg once daily for the induction studies, and with both 15 mg and 30 mg 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.