The agency decided to extend the review process after Roche submitted additional data regarding the commercial manufacturing process of the drug. The extension is not related to the safety or efficacy of Ocrevus, Roche said in a company statement.
While originally slated to make a decision by Dec. 28, the FDA will now issue its ruling by March 28.
Roche is hoping Ocrevus will become a mainstay treatment for MS patients to help boost revenue as its other best-selling drugs are facing more competition from cheaper alternatives, reports Reuters.
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