FDA approves Plegridy for relapsing Multiple Sclerosis - Biogen IDEC

Biogen Idec has announced that the FDA has on 15 August 2014, approved Plegridy (peginterferon beta-1a), a new treatment for people with relapsing forms of Multiple Sclerosis (RMS). Plegridy, the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the Plegridy Pen, a new, ready-to-use autoinjector, or a prefilled syringe.

The FDA approval of Plegridy is based on results from one of the largest pivotal studies of beta interferon conducted, ADVANCE, which involved more than 1,500 MS patients. ADVANCE was a two-year, Phase III, placebo-controlled (in year one) study that evaluated the efficacy and safety of Plegridy administered subcutaneously. The analysis for all primary and secondary efficacy endpoints occurred at the end of year one. After the first year, patients on placebo received Plegridy for the duration of the study. In the first year of the ADVANCE clinical trial, 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, by 38 percent (p=0.0383) compared to placebo. Plegridy also significantly reduced the number of new gadolinium-enhancing [Gd+] lesions by 86 percent (p<0.0001) and reduced new or newly enlarging T2-hyperintense lesions by 67 percent (p<0.0001) compared to placebo.