Bristol Myers Squibb announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. 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 3 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 U.S. Food and Drug Administration approved Zeposia for the treatment of adults with moderately to severely active UC on May 27, 2021. Bristol Myers Squibb thanks the patients and investigators involved in the True North clinical trial.