FDA approves Biogen and Alkermes’ Vumerity for relapsing multiple sclerosis
pharmafile | October 30, 2019 | News story | Research and Development, Sales and Marketing | Alkermes, Biogen, FDA, Vumerity, multiple sclerosis, pharma
The FDA has given the green light to Vumerity (diroximel fumarate), a novel oral fumarate developed by Biogen and Alkermes, for the treatment of relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
While exact details did not accompany the announcement, the approval was based on submitted data which supported the bioequivalence of Vumerity to Biogen’s own Tecfidera (dimethyl fumarate), showing that both therapies performed similarly in terms of safety and efficacy.
“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 Dr Alfred Sandrock, Jr, Executive Vice President, Research and Development, and Chief Medical Officer at Biogen. “Vumerity is a novel fumarate that offers the well-characterised efficacy of Tecfidera and has been studied for improved patient-reported gastrointestinal tolerability.”
Dr Craig Hopkinson, Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes, also remarked: “The approval of Vumerity for relapsing MS marks the culmination of a multi-year development programme 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.”
Under the terms of the pair’s partnership, Biogen owns the exclusive global commercialisation licence for Vumerity, and the company confirmed that a US launch is imminent.
Matt Fellows
Related Content
GSK’s meningococcal vaccine candidate accepted for FDA review
GSK has announced that the US Food and Drug Administration (FDA) has accepted for review …
FDA grants ODD to Candel Therapeutics’ pancreatic cancer treatment
Candel Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan …
FDA clears Oryzon’s phase 1/2 trial for lung cancer treatment
Oryzon Genomics has announced that the US Food and Drug Administration (FDA) has approved its …
