Bristol-Myers ulcerative colitis therapy under review in Europe

 

• Bristol Myers Squibb (NYSE:BMY) announces that the European Medicines Agency has validated its Marketing Authorization Application for its ulcerative colitis therapy, Zeposia (ozanimod).
• The validation confirms the submission is complete, leading to the EMA’s centralized review process, a statement from the company said. 
• FDA has already approved Zeposia for adults with relapsing forms of multiple sclerosis.
• The marketing application is supported by a pivotal, placebo-controlled Phase 3 trial as an induction and maintenance therapy in adults with moderately to severely active UC. 
• With an overall safety profile comparable to the known safety profile for approved labeling, the clinical trial has met both primary endpoints with statistical significance, the company added.  
• https://seekingalpha.com/news/3647472-bristol-myers-squibb-s-ulcerative-colitis-therapy-goes-under-review-in-europe