The US Food and Drug Administration (FDA) has approved Biogen and Alkermes’ Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis (MS).
The oral treatment has been indicated for various forms of the disease, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive variations.
Biogen, the company that holds the exclusive, worldwide license to commercialise the drug, has confirmed that it intends to make it available in the United States in the near future.
In a release, the companies confirmed that under the terms of the license and collaboration agreement, Biogen will pay Alkermes $150 million in connection with the approval.
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, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes.”
The decision was allegedly based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway, which included data from pharmacokinetic bridging studies comparing the treatment and Tecfidera (dimethyl fumarate) to establish bioequivalence, and relied, in part, on the FDA's findings of safety and efficacy for Tecfidera.
He continued, "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."
MS is a condition that can affect the brain and spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance. It's a lifelong condition that can sometimes cause serious disability.