Otsuka gains approval for Nexletol in Japan

The Japanese Ministry of Health, Labor and Welfare(MHLW) has approved Otsuka Pharmaceutical's (TYO: 4578) Nexletol (bempedoic acid)for the treatment of hypercholesterolemia and familial hypercholesterolemia.

Nexletol is an oral, non-statin treatment with a novel mechanism of action. It inhibits ACLY (adenosine triphosphate citrate lyase), an enzyme upstream of the statin target in the liver's cholesterol synthesis pathway, which ultimately leads to a reduction in blood LDL-cholesterol levels. was created by Esperion Therapeutics (Nasdaq: ESPR). Nexletol is marketed as a treatment for hypercholesterolemia in several regions around the world, including the USA and Europe. In 2020, Otsuka acquired exclusive development and commercialization rights for Nexletol in Japan from Esperion and has been advancing its development.

Some patients with hypercholesterolemia are unable to achieve their target cholesterol levels despite taking statins (insufficient response to statins), while others find it difficult to continue treatment with statins due to adverse events. Nexletol is expected to offer a new therapeutic option for these patients in Japan.