FDA Extends PDUFA Date for Biogen Idec’s Plegridy

The agency did not ask for additional studies, according to the company.

Both the FDA and the European Medicines Agency accepted BLAs for Plegridy (peginterferon beta-1a) in July. The drug is part of the interferon class of drugs, which Biogen Idec says are often used as first-line treatments for relapsing MS; Biogen Idec’s subcutaneous pegylated version extends the drug’s half-life and exposure in the body.

Plegridy was tested in a global, multi-center, randomized, double-blind, parallel-group and placebo-controlled Phase III safety and efficacy study of 1,516 patients with relapsing-remitting MS. In that study, Plegridy met all of its primary and secondary endpoints of reducing relapses, disability progression and brain lesions as compared to placebo, Biogen Idec said.

The drugmaker is working with the FDA to ensure timely review, said spokeswoman Ligia Del Bianco. The company hopes to launch the drug in the second half of this year. — Lena Freund

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