Posted by Michael Wonder on 25 Feb 2019
Alkermes and Biogen announce U.S. FDA acceptance of diroximel fumarate new drug application for multiple sclerosis
25 February 2019 - Alkermes and Biogen today announced that the U.S. FDA has accepted for review the new drug application for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis.
The application has been assigned a PDUFA target action date in the fourth quarter of 2019.
If approved, Biogen intends to market diroximel fumarate under the brand name VUMERITY, which has been conditionally accepted by the FDA and will be confirmed upon approval.
