Biogen Idec Receives Fast Track Designation For Multiple Sclerosis Drug
Trial designed to evaluate efficacy and safety of PEGylated interferon beta-1a in patients with RMS
Biogen Idec has reported that FDA has granted PEGylated interferon beta-1a (BIIB017) Fast Track designation, for relapsing multiple sclerosis (RMS).
Biogen Idec plans to enroll more than 1,200 patients in the randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of PEGylated interferon beta-1a in patients with RMS.
The trial called ADVANCE, would 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.
Michael Panzara, Vice President and CMO of neurology at Biogen Idec, said: “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. We look forward to working closely with the FDA to expedite the compound’s development and review process.”
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