CHMP recommends EU approval of Zeposia for ulcerative colitis.- BMS

Zeposia, an oral medication taken once daily,is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

The CHMP adopted this positive opinion based on data from True North, a pivotal Phase III trial evaluating Zeposia as an induction and maintenance therapy versus placebo in adult patients with moderately to severely active UC. The trial demonstrated significant improvements across all primary and secondary efficacy endpoints – including clinical remission, clinical response, endoscopic improvement and endoscopic histologic mucosal improvement – versus placebo at Week 10 and Week 52. The overall safety observed in True North was consistent with the known safety profile for Zeposia in approved labeling. The clinical findings from True North, entitled “Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis,” were published in the September 30th issue of The New England Journal of Medicine. The FDA approved Zeposia for the treatment of adults with moderately to severely active UC on May 27, 2021.