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Zeposia, the first and only oral sphingosine 1-phosphate (S1P) receptor modulator approved for ulcerative colitis1, represents a new way of treating this chronic immune-mediated disease2
Zeposia demonstrated significant improvements across all primary and key secondary efficacy endpoints – including clinical remission, clinical response, endoscopic improvement and endoscopic-histologic mucosal improvement – versus placebo at Week 10 and Week 52 in True North Phase 3 study1
First approved gastrointestinal disease treatment for Bristol Myers Squibb’s growing immunology franchise and marks the second indication for Zeposia1
Bristol Myers Squibb is committed to making Zeposia accessible to appropriate patients who need it through the Zeposia 360 Support™ program
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia® (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).1 Zeposia, an oral medication taken once daily, is the first and only sphingosine 1-phosphate (S1P) receptor modulator approved for patients with moderately to severely active UC. The mechanism by which Zeposia exerts therapeutic effects in UC is unknown but may involve the reduction of lymphocyte migration into the intestines. It is thought that by targeting S1P receptors on lymphocytes, a type of immune system cell, Zeposia reduces the number of lymphocytes in peripheral blood.1,3,4
“Despite the availability of approved therapies, there is still unmet need and an opportunity to deliver additional treatment options to help patients better manage their disease,” said Adam Lenkowsky, general manager and head, U.S., Cardiovascular, Immunology and Oncology, Bristol Myers Squibb.5 “We’re thrilled that our pursuit of transformative science in immunology may benefit patients in their ulcerative colitis treatment by introducing a new option that has a different mechanism of action than available therapies. Zeposia combines disease control through lasting remission and demonstrated safety in a once-daily pill.”1
The approval is 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. During induction at Week 10 (Zeposia N=429 versus placebo N=216) the trial met its primary endpoint of clinical remissiona (18% versus 6%, p
