Zeposia (ozanimod) is approved in Europe for moderate to severe ulcerative colitis in adults. The drug is indicated for treating patients who had an inadequate response to conventional therapy or biologics.
The approval is based on the Phase 3 True North trial, a placebo-controlled trial that evaluated the efficacy of Zeposia versus placebo in adult patients with moderately to severe ulcerative colitis. Nearly 30% of the patients failed or were intolerant to TNF blockers.
In the induction phase, at week 10, the trial met the primary endpoint (18% versus 6%), and the secondary endpoints
At week 52, the primary endpoint of clinical remission was met (37% versus 19%), and the secondary endpoints
Zeposia is a sphingosine-1 phosphate receptor modulator, which Celgene developed.