The FDA has approved AbbVie’s RINVOQ® (upadacitinib) for adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. RINVOQ® is the first oral treatment approved to this indication. The approval was based on efficacy and safety in two randomized induction trials NCT03345836 and NCT03345849.
On the same day, the National Institute for Health and Care Excellence issued final draft guidance recommending Rinvoq® as an option for eligible adults with moderate to severe active CD on the NHS in England and Wales.