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AbbVie’s Rinvoq Receives the US FDA’s Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

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AbbVie’s Rinvoq Receives the US FDA’s Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

AbbVie’s Rinvoq Receives the US FDA’s Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

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  • 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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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