Biogen, Alkermes get FDA OK for Vumerity

Biogen and Alkermes have received the Food and Drug Administration’s clearance for Vumerity (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis, or MS, 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 United States in the near future.

"The FDA's approval of Vumerity delivers on Biogen's commitment to pursue new therapies that may provide meaningful impact for people living with relapsing MS, and we look forward to bringing it to the MS community as an additional treatment option," said Alfred Sandrock, Jr., Biogen executive vice president, research and development, and chief medical officer.

"Vumerity is a novel fumarate that offers the well-characterized efficacy of Tecfidera (dimethyl fumarate) and has been studied for improved patient-reported gastrointestinal tolerability."

"The approval of Vumerity for relapsing MS marks the culmination of a multi-year development program and is the latest milestone in our mission to develop new treatments for patients living with chronic central nervous system disorders," said Craig Hopkinson, Alkermes chief medical officer and senior vice president of medicines development and medical affairs. "We are grateful to the patients and study investigators who have participated in our Vumerity clinical trials and we look forward to working with our collaboration partners at Biogen to make this new treatment available to patients."