Dominant multiple sclerosis (MS) drug maker, Biogen Idec Inc, announced yesterday that it has applied to the US Food and Drug Administration (FDA) for authorization of its third injectable MS drug.
The Biologics License Application (BLA) was submitted for approval of Plegridy (peginterferon beta-1a), a pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS). This is a new version of Biogen’s Avonex. The drugs both contain interferon beta, however Plegridy contains polyethylene glycol or peg for an increased exposure of the drug. With this added polymer, MS patients are able to take doses less frequently. Additionally, Plegridy is administered subcutaneously instead of intramuscularly for less pain.
Submission for regulatory approval was based on results from year one of the two year Phase 3 ADVANCE study, where the drug met all primary and secondary endpoints. Plegridy showed to significantly reduce disease activity including relapses, disability progression and brain lesions when compared to placebo. It showed favorable safety and tolerability profiles at one year.
“This finding demonstrates our dedication to the treatment of MS, both through the discovery of new medications and the development of innovative solutions that enhance treatment for people living with this disease,” Douglas E. Williams, PhD, Executive Vice President of Research and Development at Biogen Idec stated. “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.”
According to the company, in addition to the BLA filing with the FDA, it plans to submit a Marketing Authorization Application (MAA) for the drug to the European Medicines Agency (EMA) in the next few weeks.
Currently, Biogen’s other MS drugs include Avonex, Tecfidera and Tysabri.
Source: Biogen Idec Inc.
Last Updated: 5/22/13; 10:55PM EST