Positive CHMP opinion for Biogen Idec MS drug Plegridy

25 May 2014

US biotech firm Biogen Idec (Nasdaq: BIIB) said on Friday that it had received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for approval of its Plegridy (peginterferon beta-1a), a pegylated interferon administered subcutaneously for adults with relapsing-remitting multiple sclerosis (RRMS).

The CHMP’s positive opinion is now referred to the European Commission, which grants marketing authorization for medicines in the European Union.

US approval of the drug is still awaited in the USA, after the Food and Drug Administration has extended the initial Prescription Drug User Fee Act (PDUFA) for Plegridy by three months to allow additional time for review of the application. The agency has not asked for additional studies (The Pharma Letter March 18).

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