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)

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