Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the Japanese Ministry of Health, Labour and Welfare（MHLW）has approved 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. NEXLETOL was created by Esperion Therapeutics, Inc. (Esperion). NEXLETOL is marketed as a treatment for hypercholesterolemia in several regions around the world, including the United States and Europe. In 2020, Otsuka acquired exclusive development and commercialization rights for NEXLETOL in Japan from Esperion and has been advancing its development.
(https://www.otsuka.co.jp/en/company/newsreleases/2020/20200420_1.html)

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.

A Phase 3 trial (NCT05683340) was conducted in Japan as a placebo-controlled, randomized, multicenter, double-blind, parallel-group comparative study, in 96 patients with high LDL cholesterol and in whom statins had insufficient effect or whom statin therapy is not suitable. Trial participants were orally administered either 180 mg of NEXLETOL or a placebo once a day, for 12 weeks to evaluate the efficacy and safety of NEXLETOL. The percentage change from baseline in LDL-C at Week 12, the primary endpoint, was -25.25% in the group receiving NEXLETOL group and -3.46% in the placebo group, demonstrating positive outcomes with statistical significance compared to placebo (p<0.001). Furthermore, the safety and tolerability of NEXLETOL were favorable, and no serious adverse events were observed.

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