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Plegridy™ Review Extended for Three Months


Biogen Idec announced that the U.S. Food and Drug Administration (FDA) has extended its review of Biogen Idec’s drug candidate Plegridy™ (peginterferon beta-1a) for relapsing forms of multiple sclerosis (RMS) by another three months. Three months is the standard extension period for the Prescription Drug User Fee Act (PDUFA) date. 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, according to Biogen.

Plegridy is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body. Plegridy is a member of the interferon class of treatments, which is often used as a first-line treatment for MS. Regulatory authorities in the United States accepted the marketing applications for the review of Plegridy in RMS in 2013.


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