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ENTYVIO (védolizumab) - Pochite chronique active modérée à sévère
Opinions on drugs -
Posted on
Nov 23 2022
Reason for request
New indication
Key points
Considering all of this information and after discussions and a vote, the Committee deems that for the indication extension for the “Treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy”:
Clinical Benefit
| Insufficient |
The Committee deems that the actual clinical benefit (ACB) of ENTYVIO (vedolizumab) is insufficient to justify public funding for the extension of the marketing authorisation indication. |
Clinical Added Value
| Not applicable |
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