Biogen Idec Receives Fast Track Designation From FDA For PEGylated Interferon Beta-1a For Relapsing Multiple Sclerosis

Main Category: Multiple Sclerosis
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 09 Jul 2009 - 7:00 PDT

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Biogen Idec (NASDAQ: BIIB) announced the U.S. Food and Drug Administration (FDA) has granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). Biogen Idec is currently enrolling patients in a global Phase III study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population.

"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."

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 demonstrate the potential to address unmet medical needs.

Biogen Idec plans to enroll more than 1,200 patients in the Phase III, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of PEGylated interferon beta-1a in patients with RMS. The global trial, called ADVANCE, will determine the efficacy of PEGylated interferon beta-1a in reducing relapse rates in patients with RMS at one year. The study will also examine if, over time, treatment with PEGylated interferon beta-1a can slow disease progression and lead to a decrease in the number of T2 hyperintense brain lesions commonly seen in MS patients.

Source
Biogen Idec