Peginterferon beta-1a (Biogen) success in ADVANCE study for MS

Biogen Idec released the primary efficacy analysis and safety data from its Phase III pivotal clinical trial, ADVANCE. 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, enabling study of a less frequent dosing schedule. The primary endpoint of ADVANCE, annualized relapse rate (ARR) at one year, was met for both the two-week and four-week dose regimens. Results showed that peginterferon beta-1a also met the secondary endpoints of risk of 12-week confirmed disability progression, proportion of patients who relapsed and magnetic resonance imaging (MRI) assessments for both dose regimens. Adverse events (AEs), serious adverse events (SAEs) and discontinuations due to AEs were similar across both dose groups. Overall with both dose regimens studied, the risk-benefit profile of peginterferon beta-1a appears to be favorable.