Positive Results for Phase 3 Study of Peginterferon Beta-1a in Multiple Sclerosis

Biogen Idec announced the primary efficacy analysis and safety data from its Phase 3 pivotal clinical trial, ADVANCE. The results support peginterferon beta-1a as a potential treatment dosed every two weeks or every four weeks 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. This enables the study of a less frequent dosing schedule.

ADVANCE is a global, multi-center, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the efficacy and safety of peginterferon beta-1a in 1,516 randomized patients with RRMS over two years. The study evaluated the two dose regimens of peginterferon beta 1-a, 125mcg administered SC every two weeks or every four weeks compared to placebo. After the first year, patients taking placebo were re-randomized to one of the peginterferon beta-1a arms for the duration of the second year of the study. The study met its primary endpoint of annualized relapse rate (ARR) at one year for both the two-week and four-week dose regimens. Compared to placebo, ARR reduction with two-week dosing was 35.6 percent (p<0.001) and with four-week dosing was 27.5 percent (p<0.02).

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