Diplomat has announced that it will distribute Plegridy (peginterferon beta-1a). Manufactured by Biogen Idec, Plegridy was approved on 15 August 2014 by the US Food and Drug Administration for the treatment of relapsing forms of multiple sclerosis (RMS). Plegridy is the only pegylated beta interferon approved for use in RMS and is dosed once every two weeks. Plegridy can be administered subcutaneously with the Plegridy Pen, a new, ready-to-use autoinjector, or a prefilled syringe.
The approval of Plegridy comes as a result of the one of the largest pivotal studies of beta interferon conducted, ADVANCE, which included more than 1,500 multiple sclerosis patients. ADVANCE was a two-year, phase 3, placebo-controlled study that evaluated the efficacy and safety of Plegridy administered subcutaneously. The ADVANCE study demonstrated a reduction in relapses, disability progression and the number of multiple sclerosis lesions in comparison to the results with placebo.