EMA validates Zeposia MAA

29 December 2020

US drugmaker Bristol Myers Squibb (NYSE: BMY) has announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for Zeposia (ozanimod) for the treatment of moderately to severely active ulcerative colitis (UC).

Zeposia has been approved in both Europe and the USA in multiple sclerosis indications, but not yet to treat UC in any country.

The MAA submitted to the EMA is based on results from True North, a pivotal, placebo-controlled Phase III trial evaluating the oral treatment as an induction and maintenance therapy in adults with moderately to severely active UC.

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