Posted by Michael Wonder on 18 Dec 2018
Alkermes and Biogen announce submission of a new drug application to U.S. FDA for diroximel fumarate in multiple sclerosis
17 December 2018 - Alkermes and Biogen today announced that Alkermes has submitted a new drug application to the U.S. FDA for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing forms of multiple sclerosis.
Alkermes is seeking approval of diroximel fumarate under the 505(b)(2) regulatory pathway, and the submission includes data from EVOLVE-1, a phase 3 pivotal trial that evaluated long-term safety in relapsing-remitting MS with approximately 700 patients dosed with diroximel fumarate.
If approved, Biogen intends to market diroximel fumarate under the brand name Vumerity. This name has been conditionally accepted by the FDA and will be confirmed upon approval.
