人福医药:二十碳五烯酸乙酯软胶囊获药品注册证书

Core Viewpoint - The announcement highlights the approval of a new drug, Eicosapentaenoic Acid Ethyl Ester Soft Capsules, by the National Medical Products Administration, aimed at treating severe hypertriglyceridemia and reducing cardiovascular event risks in specific patient populations [1] Group 1: Drug Approval - The drug has received a registration certificate from the National Medical Products Administration [1] - It is intended for adult patients with severe hypertriglyceridemia (≥500 mg/dL) [1] - The drug is to be used in conjunction with dietary control to lower triglyceride levels [1] Group 2: Indications and Usage - The drug is indicated for use alongside statins in patients diagnosed with cardiovascular diseases or diabetes who have two or more additional cardiovascular risk factors and hypertriglyceridemia (≥150 mg/dL) [1] - It aims to reduce the risk of cardiovascular events such as myocardial infarction, stroke, coronary artery revascularization, and unstable angina requiring hospitalization [1]