U.S., EU Regulators to Review Pfizer's Ulcerative Colitis Treatment
December 21 2022 - 07:40AM
Dow Jones News
By Dean Seal
Pfizer Inc. said U.S. and European regulators have agreed to
review its ulcerative colitis treatment etrasimod after two recent
trials demonstrated significant clinical remission compared with a
placebo.
The New York-based drug company said Wednesday that the U.S.
Food and Drug Administration has accepted its New Drug Application
for etrasimod for individuals living with moderately to severely
active ulcerative colitis.
The European Medicines Agency has also accepted a Marketing
Authorization Application for the treatment in the same patient
population, Pfizer said.
The FDA's decision is expected in the second half of next year,
Pfizer said, while the EMA's is expected in the first half of
2024.
Pfizer submitted the applications based on two Phase 3 trials of
etrasimod for ulcerative colitis patients who had previously failed
or were intolerant to at least one conventional, biologic or Janus
kinase inhibitor therapy. Both studies achieved all primary and key
secondary endpoints and carried a safety profile consistent with
previous studies.
Write to Dean Seal at dean.seal@wsj.com
(END) Dow Jones Newswires
December 21, 2022 07:25 ET (12:25 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
Pfizer (NYSE:PFE)
Historical Stock Chart
From May 2023 to Jun 2023
Pfizer (NYSE:PFE)
Historical Stock Chart
From Jun 2022 to Jun 2023
