Case Study: 505(b)(2) filing pathway – USFDA approval of Vumerity

Biogen, global biotechnology company, and Alkermes, global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved Vumerity (diroximel fumarate), a novel oral fumarate with a distinct chemical structure, for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

Biogen holds the exclusive, worldwide license to commercialize Vumerity and intends to make it available in the United States in the near future.

Approval Pathway:

The FDA approval of Vumerity 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.

Tecfidera® (dimethyl fumarate), a twice-daily pill for relapsing MS

Vumerity is diroximel fumarate.

Why 505(b)(2) filing pathway is accepted by USFDA for Vumerity?

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.

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What is 505(b)(2) filing pathway, filing, guidance  >> Learn more

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Licensing and collaboration of Vumerity

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 amortized over the expected useful life of the product. Alkermes is also 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 as set forth in the agreement.