AbbVie’s Rinvoq Receives the US FDA’s Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
Shots:
- The approval is based on efficacy and safety data from P-III clinical studies (U-ACHIEVE and U-ACCOMPLISH) evaluating Rinvoq (45mg, qd, 8wks.) and 15/30mg, qd for the maintenance study (U-ACHIEVE maintenance) through 52wks.
- Rinvoq achieved 1EPs of clinical remission per modified Mayo Score [mMS]) @8 & 52wks, patients achieved 1EPs as early as week 2 and steroid-free clinical remission @1yrs.
- The study met all its 2EPs, including endoscopic improvement, HEMI, as well as corticosteroid-free clinical remission in the maintenance study. Rinvoq is a JAK inhibitor and this approval marks the first indication in gastroenterology
Ref: PR Newswire | Image: AbbVie
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