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AbbVie Receives European Medicine Agency Committee's Recommendation for Approval of Severe Bowel Disease Drug Candidate
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AbbVie Receives European Medicine Agency Committee's Recommendation for Approval of Severe Bowel Disease Drug Candidate
May 31, 2024 1:54 AM

04:35 AM EDT, 05/31/2024 (MT Newswires) -- AbbVie ( ABBV ) said Friday that the European Medicines Agency's advisory committee recommended approval of risankizumab for treating adults with moderately to severely active ulcerative colitis who have not responded adequately to conventional or biologic therapy.

The Committee for Medical Products for Human Use's recommendation was based on two phase 2 trials, which met the primary endpoint of clinical remission and key secondary endpoints, including endoscopic improvement in patients on the treatment.

The final European Commission decision is expected in Q3.

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