Ozanimod Wins FDA Approval in Ulcerative Colitis

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Ozanimod (Zeposia) was approved by the FDA to treat ulcerative colitis in adults, Bristol Myers Squibb said on Thursday.

The once-daily oral medication is the first sphingosine 1-phosphate (S1P) receptor modulator approved for the disease and is indicated for moderately to severely active ulcerative colitis, a form of chronic inflammatory bowel disease. S1P receptor modulators are thought to reduce lymphocyte migration into the intestines, though its therapeutic mechanism is unknown, according to the manufacturer. Ozanimod was initially approved in 2020 to treat relapsing forms of multiple sclerosis.

Approval in ulcerative colitis was based on data from a phase III trial, True North, which evaluated ozanimod versus placebo for adults with moderate to severe ulcerative colitis.

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The study met its primary endpoint, significantly improving clinical remission at 10 weeks (18% vs 6%, respectively) and during maintenance at 52 weeks (37% vs 19%; P<0.0001 for both). At week 10, the drug met its secondary endpoints of endoscopic improvement (46% vs 26%), clinical response (48% vs 26%), and endoscopic-histological mucosal improvement (13% vs 4% respectively; P<0.001 for all).

“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, of the Swedish Medical Center in Seattle, said in a statement. “Zeposia has the potential to be an important new treatment option for adult patients with moderate to severe ulcerative colitis.”

The drug is contraindicated for patients with serious cardiovascular conditions in the last 6 months, including myocardial infarction, unstable angina, stroke, transient ischemic attack, or decompensated heart failure requiring hospitalization. Patients with untreated sleep apnea and patients taking a monoamine oxidase inhibitor should not take the drug.

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Adverse events from systemic use may include increased risk of infections, bradyarrhythmia and atrioventricular conduction delays, liver injury, fetal risk, increased blood pressure, respiratory effects, and macular edema. Common adverse events reported in 4% or more of trial participants were headache, upper respiratory infection, and elevated liver enzymes.

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    Zaina Hamza is a staff writer for MedPage Today, covering Gastroenterology and Infectious disease. She is based in Chicago.

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