Ozanimod receives refusal-to-file for relapsing multiple sclerosis

On 27 February 2018, Celgene (NJ, USA) announced that it received a refusal-to-file letter from the US FDA with concerns about the marketing application for ozanimod in the treatment of patients with relapsing forms of multiple sclerosis. Last month, Celgene had predicted it would expect US approval of ozanimod by the end of this year and planned to file for European approval during the current quarter. However, the company explained that following a preliminary review, the FDA had concluded that the non-clinical and clinical pharmacology sections in the submission were not sufficient to allow a complete review. In May last...