Biogen Idec announced that the Food and Drug Administration (FDA) has approved Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (RMS). Plegridy is the only pegylated beta interferon approved for use in RMS.

The approval of Plegridy is supported by results from the ADVANCE study, which involved more than 1,500 MS patients. ADVANCE was a Phase 3, two-year, placebo-controlled (in Year 1) study that evaluated the efficacy and safety of Plegridy administered subcutaneously. In the first year of Plegridy dosed once every two weeks significantly reduced annualized relapse rate (ARR) at one year by 36% vs. placebo (P=0.0007).

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Plegridy also reduced the risk of 12-week confirmed disability progression by 38% (P=0.0383) vs. placebo, and also significantly reduced the number of new gadolinium-enhancing [Gd+] lesions by 86% (P<0.0001).

Plegridy will be available as a 125mcg single-dose prefilled pen in 2-count cartons, and as a 125mcg single-dose prefilled syringe in 2-count cartons. Both pen and syringe formulations are also supplied as Starter Packs.

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