Benzinga | Oct 15, 2021 07:00AM EDT

Bristol Myers Squibb Reports Received Positive CHMP Opinion For Zeposia As Treatment For Adults With Moderately To Severely Active Ulcerative Colitis

CHMP recommendation based on positive results from the Phase 3 True North study, in which Zeposia demonstrated clinically meaningful improvements in key clinical, endoscopic and mucosal healing endpoints

If approved by the European Commission, Zeposia will become the first and only oral sphingosine 1-phosphate (S1P) receptor modulator approved for ulcerative colitis in the European Union

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today 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).

"Despite available therapies, many people living with ulcerative colitis struggle to effectively manage this often relentless and unpredictable disease, making the availability of different treatment options extremely important," said Jonathan Sadeh, M.D., MSc., senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb. "With this positive recommendation from the CHMP, we are one step closer to bringing Zeposia, which has the potential to be a truly transformative medicine, and the first and only oral S1P receptor modulator for ulcerative colitis, to appropriate patients in the EU living with the disease."

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 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 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.