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Zeposia brings a new way of treating this chronic immune-mediated disease, approved for 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 is the first and only oral sphingosine 1-phosphate (S1P) receptor modulator for UC, with this approval marking its second indication in the European Union
Zeposia approval is based on the Phase 3 True North trial, which demonstrated clinically meaningful improvements in key clinical, endoscopic and mucosal healing endpoints, with no new safety signals observed
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced the European Commission has granted a Marketing Authorization for 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). Zeposia is the first and only oral S1P receptor modulator approved for UC, and represents a new way of treating this chronic immune-mediated disease.
“With today’s European Commission approval of Zeposia for ulcerative colitis, patients and physicians now have a once-daily oral treatment option to help address this debilitating disease, with a demonstrated efficacy and safety profile and a different mechanism of action than other available therapies,” said Jonathan Sadeh, M.D., MSc., senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb. “We are proud of our heritage in transformational science and innovative medicines that has brought us to this stage and look forward to offering appropriate patients in Europe a new therapy that provides significant symptom relief and lasting clinical remission.”
The approval was 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. Key findings from the trial include:
