ARTICLE | Company News
FDA extends review of Biogen Idec's Plegridy
March 19, 2014 12:41 AM UTC
Biogen Idec Inc. (NASDAQ:BIIB) said FDA extended by three months its review of a BLA for Plegridy peginterferon beta-1a ( BIIB017) to treat relapsing forms of multiple sclerosis (MS). According to the company, the agency said it needed more time to review the application, but Biogen Idec declined to provide details. The company also declined to disclose the new or original PDUFA date, but said it now expects a decision from FDA on the application next half. The company submitted the BLA in May 2013. ...