Biogen and Alkermes announced U.S. Food and Drug Administration approved Vumerity™ (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Biogen holds the exclusive, worldwide license to commercialize Vumerity and intends to make it available in the U.S. in the near future.
 
The FDA approval of Vumerity was based on a New Drug Application. It included data from studies comparing Vumerity and Tecfidera to establish bioequivalence, and partly relied on the FDA’s safety and efficacy findings for Tecfidera. Interim results from an EVOLVE-MS-1 study at the time of NDA submission included a low overall rate of patients who stopped using Vumerity because of adverse events, and a rate of less than 1 percent of patients who stopped using Vumerity because of adverse gastrointestinal events.