Biogen Files For Avonex MS Drug In USA

Biogen has filed a New Drug Application with the US Food and Drug Administration for Avonex (recombinant interferon beta-1a), a treatment for multiple sclerosis. Earlier this month, the company filed a similar application with the European Medicines Evaluation Agency (Marketletter May 8).

Last October, Biogen announced Phase III trial results of Avonex which showed a 75% increase in predicted time to disability and a one-third reduction in the exacerbation rate. This was the first time a drug in a blinded clinical trial slowed the progression of disability in MS, according to the company. The data from this Phase III trial have been submitted for publication and are expected to appear in print in the next few months.

Avonex is the first proprietary drug for which Biogen has filed a submission dossier, according to Jim Vincent, Biogen's chairman and chief executive.