Posted by Michael Wonder on 23 May 2022
CHMP recommends European Commission approval of upadacitinib (Rinvoq) for the treatment of adults with moderate to severe ulcerative colitis
23 May 2022 - CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one for maintenance.
AbbVie today announced the EMA's 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 who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
