科進製藥 (科懋) 獲 治療三酸甘油酯”國產”新成份新藥證 (Omega-3-Acid Ethyl Esters)

科懋生技:本公司100%持有之子公司科進公司新成份新藥脂妙清軟膠囊 1000毫克（Omacor Soft Capsules 1000mg）通過台灣TFDA 查驗登記取得藥證。 鉅亨網新聞中心(來源：台灣證券交易所)2016-04-13第二條第51款1.事實發生日:105/04/122.公司名稱:科進製藥科技股份有限公司3.與公司關係[請輸入本公司或子公司]:子公司4.相互持股比例:科懋生技持有科進製藥100%股份5.傳播媒體名稱:不適用6.報導內容:不適用7.發生緣由:本公司子公司國產新成份新藥脂妙清軟膠囊1000毫克「Omacor (Omega-3-Acid Ethyl Esters 90) Soft Capsules 1000mg） 獲得台灣衛生福利部食品藥物管理署（TFDA）通過查驗登記 核發藥品許可證，許可證字號：衛部藥製字第059019號， 適應症為高三酸甘油酯(血)症。8.因應措施: 無9.其他應敘明事項: 無

A Comparative Overview of Prescription Omega-3 Fatty Acid Products. P T. 2015 Dec;40(12):826-57. Prescription omega-3 fatty acid products (RxOM3FAs) are approved for use as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG levels of 500 mg/dL or more). These products contain the long-chain omega-3 fatty acids (OM3FAs) docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA).5 RxOM3FAs containing both DHA and EPA include Lovaza (omega-3-acid ethyl esters, GlaxoSmithKline) and generic versions of Lovaza (various manufacturers); Omtryg (omega-3-acid ethyl esters A, Trygg Pharma, Inc.), and Epanova (omega-3-carboxylic acids, AstraZeneca Pharmaceuticals LP). Vascepa (icosapent ethyl, Amarin Pharma Inc.) contains only the purified ethyl ester of EPA. The efficacy of these RxOM3FAs in terms of lowering TG for patients with very high TG levels (500 mg/dL or more) as well as high TG levels (200–499 mg/dL) is well established; however, additional factors, such as differential effects on other atherogenic parameters, potential impact on cardiovascular (CV) outcomes, and cost-effectiveness, are relevant considerations in the managed care setting. This commentary will provide an overview of hypertriglyceridemia; briefly summarize the pharmacology, efficacy, and safety of RxOM3FAs; and discuss important issues in the treatment of hypertriglyceridemia levels with RxOM3FAs, including cost, effects on parameters beyond TGs, and the potential impact on CV outcomes.