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Alkermes-Biogen's MS therapy receives tentative approval from US FDA

Alkermes PLC and its partner Biogen Inc. received the U.S. Food and Drug Administration's tentative approval for Vumerity to treat multiple sclerosis.

MS is a chronic inflammatory disease in which nerve damage disrupts communication between the brain and body. In relapsing-remitting MS, patients experience flare-ups or relapses of the disease's symptoms. Between flare-ups, patients have periods of partial or complete recovery, called remission.

Vumerity, or diroximel fumarate, showed a lower risk of gastrointestinal distress in patients compared to Biogen's own previously approved therapy, Tecfidera, in a late-stage study dubbed Evolve-MS-2.

The FDA said final approval of the drug is subject to expiration of a period of patent protection. Alkermes said it believes this period relates to the term of a patent of the reference listed drug — Tecfidera — set to expire Oct. 20.

Dublin-based Alkermes licensed diroximel fumarate to Cambridge, Mass.-based Biogen in 2017, and agreed to maintain responsibility for regulatory interactions with the FDA.