Posted by Michael Wonder on 21 Dec 2022
Pfizer announces FDA and EMA acceptance of etrasimod regulatory submissions for ulcerative colitis
21 December 2022 - Filings based on two Phase 3 trials demonstrating significant clinical remission versus placebo and safety profile consistent with previous studies.
Pfizer announced today that the US FDA has accepted for review a new drug application for etrasimod for individuals living with moderately to severely active ulcerative colitis.
The EMA has also accepted the marketing authorisation application for etrasimod in the same patient population with the decision anticipated in the first half of 2024.
