Biogen Idec announced positive full first-year results from its Phase 3 ADVANCE study of Plegridy (peginterferon beta-1a) for relapsing-remitting multiple sclerosis (RRMS). Peginterferon beta-1a is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body.
The two-year Phase 3 ADVANCE clinical trial is designed to evaluate the efficacy and safety of Plegridy in 1,516 patients with RRMS. The study investigates Plegridy 125mcg administered subcutaneously every two weeks or every four weeks compared to placebo.
Plegridy met the primary endpoint of reducing annualized relapse rate (ARR) at one year by 36% compared to placebo (P=0.0007) in the two-week dosing arm. Plegridy dosed every four weeks was also shown to be effective, and met the primary and secondary endpoints in the trial. Further secondary endpoint results support that Plegridy significantly reduced multiple sclerosis disease activity, including relapses, disability progression and brain lesions, compared to placebo at one year.
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