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.