Biogen Idec on Tuesday filed for FDA approval of Plegridy (peginterferon beta-1a), an injectable therapy designed for the treatment of relapsing forms of multiple sclerosis (RMS). "We believe that based on the efficacy and safety Plegridy has demonstrated, in addition to its less frequent dosing schedule, it has the potential to become a preferred interferon treatment option," remarked executive vice president of R&D Douglas E. Williams.
The submission was based on results from the first year of the two-year Phase III ADVANCE study, which included 1516 patients with relapsing-remitting MS. Data from the trial demonstrated that Plegridy significantly reduced MS disease activity, including relapses, disability progression and brain lesions, compared to placebo at one year. The therapy also showed favourable safety and tolerability profiles at one year.
In addition to the FDA filing, Biogen Idec indicated that it plans to submit the therapy for review in Europe in the coming weeks. Company officials suggested that if approved, many physicians will shift patients to the new treatment from other MS treatments, including Biogen Idec’s Avonex (interferon beta-1a), the earlier drug on which Plegridy is based.
For further analysis, read ViewPoints: Biogen Idec looks to follow Tecfidera success with pegylated Avonex approval.
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