Today Biogen Idec (NASDAQ: BIIB) announced it has submitted a Biologics License Application (BLA) to the U.S. 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 (RMS).
This regulatory submission was based on the results from the first year of 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.
"This filing 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," said Douglas E. Williams, Ph.D., 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 the BLA filing with the FDA, Biogen Idec plans to submit a Marketing Authorisation Application (MAA) for PLEGRIDY to the European Medicines Agency (EMA) in the coming weeks.
Biogen Idec has been the leader in the development of MS therapies for three decades and its robust treatment portfolio and development pipeline provides options that may help manage the disease from its earliest signs through its later stages.
The company anticipates hearing from regulatory authorities regarding the status and acceptance of these submissions within the next couple of months.
Source Biogen Idec