Relapsing multiple sclerosis drug approved by FDA

The US Food and Drug Administration (FDA) has announced that VUMERITY™ (diroximel fumarate) has been approved. The drug is for the treatment of patients with relapsing forms of multiple sclerosis (MS) and will be available in the US soon.

VUMERITY, produced by Biogen and Alkermes, is a novel oral fumarate with a distinct chemical structure approved for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Once in the body, VUMERITY rapidly converts to monomethyl fumarate, the same active metabolite of dimethyl fumarate.

The FDA approval of the drug was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. It included data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA^® to establish bioequivalence and relied, in part, on the FDA’s findings of safety and efficacy for TECFIDERA.

“VUMERITY is a novel fumarate that offers the well-characterised efficacy of TECFIDERA (dimethyl fumarate) and has been studied for improved patient-reported gastrointestinal tolerability,” said Dr Alfred Sandrock, executive vice president, research and development, and chief medical officer at Biogen.

Under the terms of the license and collaboration agreement between Biogen and Alkermes, Biogen will pay Alkermes $150 million in connection with the FDA’s approval of VUMERITY.

Biogen plans to account for this milestone payment as an asset that will be amortised over the expected life of the product. Alkermes is also entitled to receive a mid-teens percentage royalty on worldwide net commercial sales of the drug, subject to minimum annual payments for the first five years following FDA approval.