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Bristol Myers Squibb seeks to speed the FDA's review of Zeposia

Inherited in Bristol Myers Squibb’s buyout of Celgene, Zeposia is already on the market helping those affected by multiple sclerosis.  Yet BMS cashed in on a priority review voucher of the S1P modulator for a potential approval in ulcerative colitis.

“People living with ulcerative colitis often struggle to manage their disease and can face a severe impact to their lives, highlighting a need for new oral treatment options with proven safety and efficacy profiles that can be utilized early in the treatment journey,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “We look forward to continuing to work with the FDA to bring Zeposia to those living with this serious, chronic disease.”

The pharmaceutical giant isn’t entirely sure by which means Zeposia (Ozanimod) works in those with UC, yet they hypothesize that it may be the drugs ability to reduce lymphocyte migration into inflamed intestinal tissues. According to data retrieved from the phase 3 True North study, Zeposia helped more patients with active moderate-to-severe ulcerative colitis reach clinical remission after 10 weeks of treatment than the placebo did. Remission was achieved for 18.4% of patients receiving  Zeposia compared to 6.8% for those taking the placebo. Additionally, 37% of patients taking Zeposia maintained remission at week 52, compared to 18.5% for the placebo group.

The FDA is scheduled to respond to this request by May 30, just one year and five days after the drugs original approval. If approved, Zeposia would be the first oral sphingosine-1-phosphate (S1P) receptor modulator for the treatment of ulcerative colitis.

  1. “Bristol Myers Squibb Application For Zeposia® (Ozanimod) For The Treatment Of Ulcerative Colitis Accepted For Filing With Priority Review By U.S. Food And Drug Administration”. Investors.Bms.Com, 2021, https://investors.bms.com/iframes/press-releases/press-release-details/2021/Bristol-Myers-Squibb-Application-for-Zeposia-ozanimod-for-the-Treatment-of-Ulcerative-Colitis-Accepted-for-Filing-with-Priority-Review-by-U.S.-Food-and-Drug-Administration/default.aspx.
  2. “An MS Drug For Ulcerative Colitis? Bristol Myers Steps In FDA Fast Lane To Know The Fate Of Zeposia”. Fiercepharma, 2021, https://www.fiercepharma.com/marketing/ms-drug-for-ulcerative-colitis-bristol-myers-steps-fda-fast-lane-to-know-fate-zeposia.

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