Biogen, Alkermes Get FDA Approval for MS Drug

Biogen and Alkermes announced on Oct. 30, 2019 that FDA approved Vumerity (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for treating relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Biogen holds the exclusive, worldwide license to commercialize the drug and intends to make it available in the United States in the near future.

FDA’s approval was based on a new drug application submitted under the 505(b)(2) filing pathway, which included data from pharmacokinetic bridging studies comparing Vumerity and Tecfidera (dimethyl fumarate) to establish bioequivalence. The approval also relied, in part, on FDA’s findings of safety and efficacy for Tecfidera.

Under the terms of a license and collaboration agreement between Biogen and Alkermes, Biogen will pay Alkermes $150 million in connection with FDA’s approval. Alkermes is also entitled to receive a mid-teens percentage royalty on worldwide net commercial sales of the drug, subject, under certain circumstances, to minimum annual payments for the first five years following FDA approval and customary reductions as set forth in their agreement.

“[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., MD, PhD, executive vice-president, research and development, and chief medical officer at Biogen, in a company 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.”

“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, MD, chief medical officer and senior vice-president of medicines development and medical affairs at Alkermes, in the press release. “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.”

Source: Biogen