The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ozanimod (Zeposia®; Bristol Myers Squibb) for the treatment of adults with moderately to severely active ulcerative colitis (UC).
The sNDA submission is supported by data from the double-blind, placebo-controlled phase 3 True North trial that assessed the efficacy and safety of ozanimod as an induction and maintenance therapy for adults with moderately to severely active UC who had an inadequate response to prior treatment.
In the induction phase, patients were randomly assigned to receive either ozanimod 1mg orally once daily (n=429) or placebo (n=216) for 10 weeks. Patients who achieved a clinical response in the induction phase or who were part of an open-label arm (n=367) were eligible to proceed into the maintenance phase, in which they were randomly assigned to receive ozanimod (n=230) or placebo (n=227) through week 52.
Results showed that ozanimod met both primary end points achieving statistically significant clinical remission at week 10 in the induction phase (18.4% vs 6% for placebo; P <.0001) and at week 52 in the maintenance phase (37% vs 18.5% for placebo; P <.0001).
Additionally, ozanimod met key secondary end points achieving clinical response, endoscopic improvement, and mucosal healing at week 10 (47.8% vs 25.9% for placebo; P <.0001) and at week 52 (60% vs 41% for placebo; P <.0001); results were found to be consistent across subgroups. The safety profile of ozanimod was found to be similar to that seen in previous studies.
A Prescription Drug User Fee Act (PDUFA) target date of May 30, 2021 for this application.
Ozanimod, a sphingosine 1-phosphate receptor modulator, is marketed under the trade name Zeposia and is currently indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
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. [press release]. Princeton, NJ: Bristol Myers Squibb; February 1, 2021.