Bristol Myers Squibb today announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC). Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.

The MAA submitted to the EMA is based on results from True North, a pivotal, placebo-controlled Phase 3 trial evaluating Zeposia as an induction and maintenance therapy in adults with moderately to severely active UC. True North met both primary endpoints, demonstrating highly statistically significant and clinically meaningful results for clinical remission compared to placebo at induction at Week 10 and in maintenance at Week 52. The overall safety observed in True North was consistent with the known safety profile for Zeposia in approved labeling.

“Ulcerative colitis is an unpredictable and potentially debilitating disease, and many patients cycle through different therapies as they try to manage their disease,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “This validation is an important step toward making Zeposia available to eligible patients in the European Union, who are in need of new treatment options offering proven efficacy and safety, as well as oral administration.”