EC approval for Rinvoq in fifth indication

AbbVie's (NYSE: ABBV) Rinvoq (upadacitinib) has been approved by the European Commission for the treatment of adults 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.

The approval is based on the results of the US drugmaker's three Phase III studies. In these trials, Rinvoq achieved the primary endpoint of clinical remission at week eight in induction studies and week 52 in the maintenance study, and all secondary endpoints, including clinical response and mucosal healing.

Safety results in UC were generally consistent with the known safety profile of Rinvoq, with no new important safety risks observed.