Pfizer’s Etrasimod Receives the US FDA’s Approval for Adults with Moderately to Severely Active Ulcerative Colitis
Shots:
- The approval was based on the P-III registrational program (ELEVATE UC 52 & 12) evaluating etrasimod (2mg, qd) vs PBO in UC patients who had previously failed or were intolerant to one conventional, biologic, or JAK inhibitor therapy
- Both studies meet all primary & key secondary efficacy EPs with a favorable safety profile. In the (ELEVATE UC 52) study, clinical remission was 27.0% vs 7.0% at 12wk. & 32.0% vs 7.0% at 52wk. while 26.0% vs 15.0% in (ELEVATE UC 12) study
- All key secondary efficacy EP were met at 12wk. incl. endoscopic improvement and mucosal healing. The safety of etrasimod was consistent with previous studies. The EMA has accepted the MAA for etrasimod with an expected decision at the beginning of 2024
Ref: PR Newswire | Image: Pfizer
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