Biogen Idec announced that it has submitted a Biologics License Application to the US Food and Drug Administration (FDA) for approval of Plegridy (peginterferon beta-1a), the company’s pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis.
This regulatory submission was based on the results from the first year of the two-year global phase III 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 favourable safety and tolerability profiles at one year.
“This filing demonstrates our dedication to the treatment of multiple sclerosis, both through the discovery of new medications and the development of innovative solutions that enhance treatment for people living with this disease,” said Douglas E Williams, Biogen Idec’s executive vice president of Research and Development. “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.”
In addition to filing with the FDA, Biogen Idec plans to submit a Marketing Authorisation Application for Plegridy to the European Medicines Agency in the coming weeks.
Biogen’s portfolio against multiple sclerosis includes Tysabri (natalizumab) and the oral drug Tecfidera (dimethyl fumarate).