Biogen Idec (BIIB) has 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, a pegylated interferon administered subcutaneously for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP’s positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the EU. The CHMP’s positive opinion for PLEGRIDY marks an important milestone in bringing a meaningful treatment advance to people with MS in the EU, said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. We believe PLEGRIDY will offer physicians and those living with MS a unique treatment option that combines efficacy, a favorable safety profile consistent with the established interferon class, and a once-every-two-week dosing schedule.The CHMP opinion is primarily based on Phase 3 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 demonstrated that PLEGRIDY, dosed once every two weeks, significantly reduced annualized relapse rate (ARR) at one year by 36% compared to placebo and reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38%. Treatment also significantly reduced the number of new or newly enlarging T2-hyperintense lesions compared to placebo. Shares of BIIB are up $3.31, or 1.10%, at $303.00 in pre-market trading with a 52-week range of $194.66 – $358.89.
Biogen Idec (BIIB) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing