The U.S. Food and Drug Administration (FDA) has approved Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease (SPMS).
Taken orally, Vumerity is able to regulate immune responses and lower oxidative stress, helping to prevent the degeneration of myelin (the protective coat of nerve cells) in MS patients without inducing a systemic inhibition of the immune system.
The therapy is rapidly converted into monomethyl fumarate (MMF), and although its mode of action is not fully understood, MMF is believed to have fewer gastrointestinal side effects than Tecfidera (dimethyl fumarate, also marketed by Biogen), an FDA-approved oral therapy for relapsing MS.
“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,” Alfred Sandrock, Jr., MD, PhD, executive vice president, research and development, and chief medical officer at Biogen, said in a press release.
“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,” Sandrock added.
Craig Hopkinson, MD, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes, added: “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.
“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,” Hopkinson said.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?