FDA Approves the First S1P Modulator for Treatment of UC

The U.S. Food and Drug Administration (FDA) on May 27 approved ozanimod 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC).

The sphingosine 1-phosphate (S1P) receptor modulator is thought to inhibit the migration of lymphocytes out of the lymphatic system into the colon, thus reducing inflammation.

FDA approved ozanimod based on data from the pivotal Phase 3 TRUE NORTH trial. This multicenter, randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of ozanimod 0.92 mg vs placebo among patients with moderately to severely active ulcerative colitis who had had an inadequate response to or been unable to tolerate other treatments, including oral aminosalicylates, corticosteroids, immunomodulators, or biologic therapeutics.

During the induction phase, at Week 10, the trial met its primary endpoint of clinical remission (18% vs 6%) and the secondary endpoints of clinical response (48% vs 26%, p<0.0001), endoscopic improvement (27% vs 12%, p<0.0001), and endoscopic-histologic mucosal improvement (13% vs 4%, p<0.001) for ozanimod versus placebo, respectively.

At Week 52, during the maintenance phase, the TRUE NORTH trial met its primary endpoint of clinical remission (37% ozanimod vs 19% placebo, p<0.0001) and the secondary endpoints of clinical response (60% vs 41%, p<0.0001), endoscopic improvement (46% vs 26%, p<0.001), corticosteroid-free clinical remission (32% vs 17%, p<0.001), and endoscopic-histologic mucosal improvement (30% vs 14%, p<0.001), respectively.

An open-label extension trial to evaluate the longer-term profile of ozanimod is continuing, into which all eligible participants in the induction and maintenance study have been enrolled.

For more information on the TRUE NORTH trial, see www.clinicaltrials.gov, NCT02435992.

--Rebecca Mashaw

U.S. Food and Drug Administration approves Bristol Myers Squibb’s Zeposia^® (ozanimod), an oral treatment for adults with moderately to severely active ulcerative colitis. [press release] Princeton, New Jersey. May 27, 2021. Accessed May 28, 2021. https://www.businesswire.com/news/home/20210527005878/en/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibb%E2%80%99s-Zeposia%C2%AE-ozanimod-an-Oral-Treatment-for-Adults-with-Moderately-to-Severely-Active-Ulcerative-Colitis1

Accessed May 28, 2021.