Otsuka submits NDA in Japan for bempedoic acid

27 November 2024

Japanese drugmaker Otsuka (TYO: 4578) has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia.

Bempedoic acid, created by Esperion Therapeutics (Nasdaq: ESPR), has a novel mechanism of action that inhibits a cholesterol synthesis pathway by acting on ATP (adenosine triphosphate) citrate lyase, a citrate-degrading enzyme in the liver. Bempedoic acid is marketed for the treatment of hypercholesterolemia in several regions around the world, including the USA and Europe.

In 2020, Otsuka acquired exclusive development and commercialization rights for bempedoic acid in Japan from Esperion and is currently developing it domestically. The drug gained European approval in May this year and in the USA in 2020, both under the trade name Nilemdo.

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