FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Celgene Re-Submits NDA for Multiple Sclerosis Treatment

April 3, 2019
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Celgene re-filed a new drug application with the FDA for its experimental drug ozanimod for treatment of adults with relapsing forms of multiple sclerosis.

The agency issued a refused-to-file notice for the drug last year because the company failed to include key information in its NDA.

Ozanimod is viewed as one of the most promising drugs in Celgene’s product pipeline. The Summit, N.J.-based company is set to become a subsidiary of Bristol-Myers Squibb under a planned $74 billion acquisition later this year.

Armed with results from two Phase III trials involving a total of 2,600 patients, Celgene also has filed for European regulatory approval.

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