Biogen Idec Receives Notification of PDUFA Date Extension for Plegridy(TM) (Peginterferon Beta-1a)

March 18, 2014 11:35 AM

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Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for marketing approval of PLEGRIDY(TM), 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.

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