FDA OKs Rinvoq in Ulcerative Colitis

FDA has approved an AbbVie supplemental NDA for Rinvoq (upadacitinib) for treating adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. The company says the approval marks the first indication for Rinvoq in gastroenterology and is supported by efficacy and safety data from three Phase 3 randomized, double-blind, placebo-controlled clinical studies. Previously, it was FDA-approved for treating rheumatoid and psoriatic arthritis.

Approval was based on data showing that significantly more patients treated with Rinvoq achieved clinical remission at weeks 8 and 52 compared to placebo, according to the company. In addition, the studies showed endoscopic improvement and histologic-endoscopic mucosal improvement, as well as corticosteroid-free clinical remission in a maintenance study.