CHMP recommends Plegridy as a treatment for Multiple Sclerosis - Biogen IDEC

Biogen Idec received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization of Plegridy (peginterferon beta-1a), a pegylated interferon administered subcutaneously for adults with relapsing-remitting Multiple Sclerosis (RRMS).

The CHMP opinion is primarily based on Phase III data from ADVANCE, one of the largest studies conducted with an interferon treatment in MS, which included more than 1,500 MS patients. Data from the first year of ADVANCE demonstrated that Plegridy, dosed once every two weeks, significantly reduced annualized relapse rate (ARR) at one year by 36 percent compared to placebo (p=0.0007). Plegridy reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent (p=0.0383) compared to placebo. Plegridy two-year data was consistent with the positive efficacy and safety results observed in year one.