FDA Approves Ozanimod (Zeposia) for Ulcerative Colitis

Megan Brooks


May 28, 2021

The US Food and Drug Administration (FDA) has approved ozanimod (Zeposia) for adults with moderately to severely active ulcerative colitis (UC), the company has announced.

Ozanimod (0.92 mg), an oral medication taken once daily, is the first sphingosine-1-phosphate (S1P) receptor modulator approved for UC.

In March 2020, the FDA approved ozanimod for adults with relapsing forms of multiple sclerosis, as reported by Medscape Medical News.

The approval of ozanimod for UC is based on data from True North, a phase 3 placebo-controlled trial that evaluated the drug as induction therapy over 10 weeks in 645 adults (mean age, 42 years; 60% men) with moderately to severely active UC, followed by maintenance therapy over 42 weeks.

All participants in the trial had failed to respond adequately to or were intolerant of oral aminosalicylates, corticosteroids, immunomodulators, or a biologic; 30% had previously experienced treatment failure or were intolerant of tumor necrosis factor blockers. Prior to and during induction, patients were treated with oral aminosalicylates and/or corticosteroids.

During induction at week 10, the trial met its primary endpoint; significantly more patients who took ozanimod achieved clinical remission than patients who took placebo (18% vs 6%; P < .0001).

Ozanimod was also superior to placebo on the secondary endpoints of clinical response (48% vs 26%; P < .0001), endoscopic improvement (27% vs 12%; P < .0001), and endoscopic-histologic mucosal improvement (13% vs 4%; P < .001).

The trial also met its primary endpoint of clinical remission during maintenance at week 52 (37% vs 19%; P < .0001) as well as the secondary endpoints of clinical response (60% vs 41%; P < .0001), endoscopic improvement (46% vs 26%; P < .001), corticosteroid-free clinical remission (32% vs 17%; P < .001), and endoscopic-histologic mucosal improvement (30% vs 14%; P < .001).

"In True North, Zeposia demonstrated efficacy for endpoints such as clinical remission, endoscopic and histological mucosal improvement and safety. All are very relevant considerations for patients with ulcerative colitis," Michael Chiorean, MD, co-director, IBD Center, Swedish Medical Center, Seattle, Washington, said in a company news release.

"Ulcerative colitis can be debilitating and unpredictable for the people living with this chronic inflammatory bowel disease," Michael Osso, president and CEO of the Crohn's and Colitis Foundation, said in the release.

"The approval of this new oral treatment is welcome news for our community and provides hope to many patients who are looking for new options to achieve symptom relief and remission," he added.

The most common adverse reactions that occurred in patients taking ozanimod were liver function test abnormality, upper respiratory infection, and headache.

Ozanimod is contraindicated for patients with recent (past 6 months) myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III/IV heart failure; patients who have Mobitz type II second- or third-degree atrioventricular block, sick sinus syndrome, or sinoatrial heart block, unless the patient has a functioning pacemaker; patients with severe untreated sleep apnea; and patients taking a monoamine oxidase inhibitor.

Ozanimod may increase the risk for infections. Before initiating treatment, a complete blood count is required for all patients. Patients should be monitored for infection during treatment and for 3 months after stopping therapy. Treatment should not be initiated in the presence of an active infection.

Complete prescribing information and medication guide are available online.

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