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FDA Agrees to Review Plegridy (Peginterferon Beta-1a) for Treatment of Relapsing MS
The FDA has accepted for review a marketing application for Plegridy (peginterferon beta-1a, Biogen Idec), a pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (MS). The agency granted a standard review timeline, which means that an approval decision should be expected within 10 months.
The regulatory application included positive 1-year results from the 2-year global phase III ADVANCE study. In this study, Plegridy met all primary and secondary endpoints by significantly reducing disease activity, including relapses, disability progression, and brain lesions, compared with placebo, and showed favorable safety and tolerability profiles at 1 year.
Plegridy is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and to prolong its exposure in the body. The drug is a member of the interferon class of treatments, which is often used as a first-line therapy for MS.
The two-year phase III ADVANCE clinical trial was a global, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the efficacy and safety of Plegridy in 1,516 patients with relapsing–remitting MS. The study investigated two dosing regimens of Plegridy (125 mcg administered subcutaneously every 2 weeks or every 4 weeks) compared with placebo.
Source: Biogen Idec; July 19, 2013.