Fate of Biogen's Plegridy in US/EU regulators’ hands
This article was originally published in Scrip
Executive Summary
Biogen Idec's biologic license application (BLA) for its pegylated subcutaneous injectable interferon, known as Plegridy (peginterferon beta-1a), will get a standard review at the US FDA, the firm revealed on 19 July, adding that the marketing authorization application (MAA) also has been validated by the European Medicines Agency, with the company seeking approval from both regulators for the drug as a treatment for relapsing forms of multiple sclerosis (MS).