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Biogen’s MS Drug Gets Fast Track Designation

Biogen Idec's PEGylated interferon beta-1a (BIIB017) for relapsing multiple sclerosis (RMS) was granted Fast Track designation by the FDA.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Biogen Idec‘s PEGylated interferon beta-1a (BIIB017) for relapsing multiple sclerosis (RMS) was granted Fast Track designation by the FDA. Biogen plans to enroll more than 1,200 patients in a Phase III, randomized, double-blind, placebo-controlled trial that will evaluate the efficacy and safety of the drug in patients with RMS.

The FDA’s Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and have the potential to address unmet medical needs.

“Early-stage clinical trials suggest that PEGylated interferon beta-1a has the potential to offer less frequent dosing without compromising efficacy, which would be a significant development for people living with multiple sclerosis,” said Michael Panzara, M.D., M.P.H., vice president and chief medical officer of neurology at Biogen Idec. “We look forward to working closely with the FDA to expedite the compound’s development and review process.”

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