US approval has been secured by Biogen and Alkermes for Vulmerity (diroximel fumarate) or treating relapsing forms of multiple sclerosis (MS).
Biogen, which holds the exclusive worldwide license to commercialise Vulmerity, said it intends to make it available in the United States in the near future.
Vumerity is a novel fumarate that offers the efficacy of Tecfidera (dimethyl fumarate) and has been studied for improved patient-reported gastrointestinal tolerability.
The approval was based on a New Drug Application (NDA) which included data from pharmacokinetic bridging studies comparing Vumerity and Tecfidera to establish bioequivalence.
As per the company’s licensing and collaboration agreement, the approval means that Biogen will now make the milestone payment f $150 million to Alkermes.
