Today Biogen Idec (NASDAQ: BIIB) announced that U.S. and EU regulatory authorities have accepted the marketing applications for the review of PLEGRIDY™ (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (MS). The U.S. Food and Drug Administration (FDA) has accepted Biogen Idec's Biologics License Application (BLA) for marketing approval of PLEGRIDY in the United States and granted the company a standard review timeline. The Marketing Authorisation Application (MAA) of PLEGRIDY for review in the European Union was also validated by the European Medicines Agency.
“PLEGRIDY, if approved, could offer a less frequent dosing schedule, a favorable safety profile, and the potential to become the preferred interferon treatment.”
The regulatory applications included positive one-year results from the two-year global Phase 3 ADVANCE study. The data demonstrated that PLEGRIDY met all primary and secondary endpoints by significantly reducing disease activity including relapses, disability progression and brain lesions compared to placebo, and showed favorable safety and tolerability profiles at one year.
"We expect that interferons will remain an important and widely used option for patients with MS. At one-year, PLEGRIDY demonstrated significant reductions in relapses and disability progression, as well as a robust impact on several MRI endpoints," said Douglas E. Williams, Ph.D., Biogen Idec's executive vice president of Research and Development. "PLEGRIDY, if approved, could offer a less frequent dosing schedule, a favorable safety profile, and the potential to become the preferred interferon treatment."
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