Everest Medicines, Pfizer Receive FDA Clearance for Ulcerative Colitis Treatment

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Etrasimod indicated for adult patients with moderate-to-severe diagnosis.

Everest Medicines revealed that Pfizer, its licensing partner, has received FDA approval for Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC). Currently, Everest is in the process of conducting Phase III clinical trials of the medication in Asia with hopes of filing a new drug application.


"We congratulate our partner for achieving this significant milestone for UC patients who are in urgent need of new and effective treatment options and prefer the convenience of a once-daily pill. Etrasimod is a proven advanced treatment with a favorable safety profile." said Rogers Yongqing Luo, CEO, Everest Medicines, in a company press release. "Everest will advance our late-stage study as quickly as possible toward registration in China and other Asian markets as the incidence of ulcerative colitis has been rapidly increasing in the region in recent years."

Reference: Everest Medicines' Licensing Partner Pfizer Announces U.S. FDA Approves Etrasimod for Adults with Moderately to Severely Active Ulcerative Colitis. PR Newswire. October 15, 2023. Accessed October 16, 2023. https://www.prnewswire.com/news-releases/everest-medicines-licensing-partner-pfizer-announces-us-fda-approves-etrasimod-for-adults-with-moderately-to-severely-active-ulcerative-colitis-301956907.html