ZURICH, Dec 20 (Reuters) - Swiss drugmaker Roche said the U.S. Food and Drug Administration (FDA) has extended until March 28 the date for reviewing its application for multiple sclerosis drug Ocrevus.
“The extension is the result of the submission of additional data by Roche regarding the commercial manufacturing process of Ocrevus, which required additional time for FDA review. The extension is not related to the efficacy or safety of Ocrevus,” Roche said in a statement on Tuesday.
Roche is counting on Ocrevus becoming a mainstay treatment for patients suffering from the neurological disease to help it bolster revenue as other big-sellers in the Basel-based company’s portfolio face imminent patent expiration and competition from cheaper copies made by rivals. (Reporting by Silke Koltrowitz; Editing by Michael Shields)