FDA and EMA accept Pfizer’s regulatory submissions for ulcerative colitis drug
Pfizer’s S1P receptor modulator for treating ulcerative colitis, etrasimod, which was at the center of a billion-dollar buyout from Arena Pharma, has now taken another step forward.
On Wednesday, the pharma announced that the FDA had accepted for review the NDA for etrasimod in patients with “moderately-to-severely active” ulcerative colitis. Pfizer stated that the FDA’s decision will be expected in the second half of next year. Meanwhile, the EMA has also accepted the marketing authorization application for the drug in the same patient population, with that decision expected sometime in the first half of 2024.
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