Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that NEXLETOL^® (bempedoic acid) has been launched today 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).

This drug 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 received approval for NEXLETOL in Japan in September this year.

Hypercholesterolemia is a condition in which the level of LDL-cholesterol in the blood exceeds the normal range. 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.

About Otsuka

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. 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. For further information, please visit www.otsuka.co.jp/en/