ZURICH Dec 20 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)