Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the Japanese Ministry of Health, Labour and Welfare（MHLW）has approved NEXLETOL

大塚制药株式会社（Otsuka）宣布，日本厚生劳动省（MHLW）已批准NEXLETOL。

（bempedoic acid） for the treatment of hypercholesterolemia and familial hypercholesterolemia.

用于治疗高胆固醇血症和家族性高胆固醇血症的（bempedoic acid）。

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.

NEXLETOL 是一种口服的非他汀类治疗药物，具有新颖的作用机制。它抑制 ACLY（腺苷三磷酸柠檬酸裂解酶），这是肝脏胆固醇合成途径中位于他汀靶点上游的一种酶，最终导致血液中低密度脂蛋白胆固醇水平的降低。NEXLETOL 由 Esperion Therapeutics, Inc. 开发。

(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..

（Esperion）。NEXLETOL在包括美国和欧洲在内的世界多个地区被销售作为高胆固醇血症的治疗药物。2020年，大冢制药从Esperion获得了NEXLETOL在日本的独家开发和商业化权利，并一直在推进其开发。

(https://www.otsuka.co.jp/en/company/newsreleases/2020/20200420_1.html)

(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..

一些高胆固醇血症患者即使服用他汀类药物也无法达到目标胆固醇水平（对他汀类药物反应不足），而另一些患者则由于不良反应难以继续使用他汀类药物进行治疗。NEXLETOL有望为日本的这些患者提供一种新的治疗选择。

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.

在日本进行了一项三期临床试验（NCT05683340），该试验为安慰剂对照、随机、多中心、双盲、平行组对照研究，纳入了96名高LDL胆固醇患者，这些患者对他汀类药物效果不佳或不适合他汀类治疗。试验参与者每天口服180毫克的NEXLETOL或安慰剂，持续12周，以评估NEXLETOL的有效性和安全性。

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..

第12周时，LDL-C与基线相比的百分比变化（主要终点）在NEXLETOL组为-25.25%，安慰剂组为-3.46%，显示出与安慰剂相比具有统计学显著性的积极结果（p<0.001）。此外，NEXLETOL的安全性和耐受性良好，未观察到严重不良事件。

About Otsuka

关于大冢制药

Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement.

大塚制药株式会社是一家全方位的医疗保健公司，专注于激发每个人的潜能以提升其健康水平。我们的医药相关业务提供针对身体和心理健康的治疗与诊断方案。我们的营养保健品业务则支持日常健康维护与改善。

Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide..

大冢的独特产品和服务基于科学证据，并在我们的企业理念指导下进行：大冢人致力于为全球健康创造新产品。