FDA delays approval of Biogen Idec’s MS drug Plegridy

The US Food and Drug Administration has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of US biotech firm Biogen Idec’s (Nasdaq: BIIB) Biologics License Application for Plegridy (peginterferon beta-1a), a subcutaneous pegylated interferon candidate for relapsing forms of multiple sclerosis (RMS).

The PDUFA date has been extended by three months, which is the standard extension period. The FDA has indicated that the extension of the PDUFA date is required to allow additional time for review of the application. The agency has not asked for additional studies, noted Biogen Idec.

Regulatory authorities in the USA and the European Union accepted the marketing applications for the review of Plegridy in RMS last year (The Pharma Letter July 19, 2013.