Biogen Idec (BIIB) announced that it has submitted a Biologics License Application or BLA to the U.S. Food and Drug Administration or FDA for approval of Plegridy (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis or RMS.
The company stated that the 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.
In addition, the company said it plans to submit a Marketing Authorisation Application or MAA for Plegridy to the European Medicines Agency or EMA in the coming weeks.
The company noted that it anticipates hearing from regulatory authorities regarding the status and acceptance of these submissions within the next couple of months.
Plegridy is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body, enabling study of a less frequent dosing schedule. Plegridy is a member of the interferon class of treatments and, if approved, would be a new addition to this class, which is often used as a first-line treatment for MS.
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