Research & Development
Biogen Inc & Alkermes plc partnership wins FDA approval for VUMERITY for treating relapsing forms of MS
31 October 2019 -

Biogen Inc (Nasdaq:BIIB) and Alkermes plc (Nasdaq:ALKS) on Wednesday jointly announced approval from the US Food and Drug Administration (FDA) for VUMERITY (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis (MS).

According to the companies, VUMERITY is a novel oral fumarate with a distinct chemical structure approved in the US for the treatment of relapsing forms of multiple sclerosis, 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.

Biogen holds the exclusive, worldwide licence to commercialise VUMERITY and intends to make it available in the United States in the near future.

FDA approval of VUMERITY was based on the partnership's NDA submitted under the 505(b)(2) filing pathway. It included data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalence and the FDA's findings of safety and efficacy for TECFIDERA. The NDA submission included interim exposure and safety findings from EVOLVE-MS-1, an ongoing, Phase 3, single-arm, open-label, two-year safety study evaluating VUMERITY in patients with relapsing-remitting MS.

Based on the company's clinical development plan, VUMERITY demonstrated a desirable therapeutic profile option for patients. Additional exploratory efficacy endpoints in the EVOLVE-MS-1 study showed changes in clinical and radiological measures compared to baseline.

Under the terms of the licence and collaboration agreement, Biogen will pay Alkermes USD150m in connection with the FDA's approval of VUMERITY. Alkermes is entitled to receive a mid-teens percentage royalty on worldwide net commercial sales of VUMERITY, subject, under certain circumstances, to minimum annual payments for the first five years following FDA approval and customary reductions.