阿斯利康高血脂新药Epanova获FDA批准

关键词:阿斯利康,高甘油三脂血症,Epanova,ω-3游离脂肪酸,鱼油

2014年5月8日讯 /生物谷BIOON/ --阿斯利康(AstraZeneca)5月6日宣布,高血脂新药Epanova(ω-3-羧酸)获FDA批准,辅助饮食,用于降低严重高甘油三脂血症(甘油三酯水平≥500mg/升)成人患者的甘油三酯水平。该药的获批,对于阿斯利康来说是一个重要的里程碑,将加强该公司现有的心血管药物产品组合。阿斯利康表示,将进一步评估Epanova的临床属性,并鉴别可能从该药中受益的其他患者群体。

Epanova是FDA批准的首个处方ω-3游离脂肪酸,有2个剂量选择:每日2克(2粒胶囊)或4克(4粒胶囊)。Epanova的获批,对于数目庞大且正在不断增长的严重高甘油三酯患者群体来说,是个好消息。该药的疗效已在临床试验中证实,可为临床医生和患者提供一种新的重要治疗选择。Epanova是一种含涂层明胶软胶囊,包含一组源于鱼油的多不饱和脂肪酸混合物(长链ω-3和ω-6脂肪酸),能够有效降低甘油三酯,并改善其他主要血脂参数。

Epanova是一种纯的、游离脂肪酸,可为医生提供一个选择,来有效管理高甘油三脂血症,同时不会显著提高患者的药物负担。Epanova的获批,是基于一个临床开发项目的数据,包括来自III期EVOLVE试验的积极数据,该试验调查了Epanova降低高甘油三脂血症患者甘油三酯水平和其他关键参数的疗效。目前,Epanova对胰腺炎或心血管发病率和死亡风险的影响尚未确定。

Epanova由阿斯利康于2013年7月耗资4.43亿美元收购Omthera制药后获得,此次收购将增强阿斯利康后期心血管疾病药物管线。目前Epanova主要开发用于严重高甘油三脂血症患者(甘油三酯水平≥500mg/dL)的治疗。该领域中,阿斯利康将与葛兰素史克(GSK)和Amartin竞争,这2个公司均有类似的鱼油药品获批。

甘油三酯(triglycerides)是存在于血液中的一种脂质(脂肪),是机体的重要能量来源。但一些人的甘油三酯水平非常高(严重高甘油三脂血症),这意味着这类患者的血液中存在过多的脂肪,这会导致严重的并发症。在美国,有近400万严重高甘油三脂血症患者,随着相关疾病(如肥胖症和糖尿病)患病率的持续上升,严重高甘油三脂血症患者群体的数目也在不断增长。

目前,阿斯利康正在继续评估Epanova的临床属性。阿斯利康计划通过一项大规模心血管预后试验STRENGTH,在心血管疾病风险增加的混合型血脂异常患者群体中,评估Epanova联合他汀类药物对心血管预后的安全性和疗效。阿斯利康也计划开发一种固定剂量的Epanova/他汀类药物组合疗法。正在开发一种Crestor+Epanova固定剂量组合,

对于阿斯利康而言,心血管医学是一个关键领域,该公司最畅销药物为降胆固醇药物Crestor,该药属于他汀类药物。目前,阿斯利康计划通过一项大规模心血管预后试验STRENGTH,在心血管疾病风险增加的混合型血脂异常患者群体中,评估该Epanova+Crestor组合疗法对心血管预后的安全性和疗效。阿斯利康也计划开发一种Epanova/Crestor固定剂量组合药物,如果获得成功,将有望使Crestor的专营权延长至2016年以后。(生物谷Bioon.com)

英文原文:US FDA approves EPANOVA for the treatment of adults with severe hypertriglyceridaemia

Tuesday, 6 May 2014

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved EPANOVA (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia (triglyceride levels greater than or equal to 500 mg/dL).

EPANOVA is the first FDA approved prescription omega-3 in free fatty acid form. The dosage of EPANOVA is 2 grams (2 capsules) or 4 grams (4 capsules), making it the first prescription omega-3 to have a dosing option as few as two capsules once a day, with or without food.

“The FDA’s approval of EPANOVA is good news for the significant and growing population with severe hypertriglyceridaemia as it offers physicians and their patients an important new treatment option that has been proven to be effective in clinical trials,” said Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. “This approval is a significant milestone for AstraZeneca, as it strengthens our existing portfolio of cardiovascular medicines. We are committed to further assessing the clinical profile of EPANOVA and to identifying other patient groups it may benefit.”

Triglycerides are a type of lipid (fat) found in blood and an essential energy source for the body. Some people have very high triglyceride levels (severe hypertriglyceridaemia), meaning they have too much fat in their blood which can lead to serious health complications. Nearly four million American adults currently have severe hypertriglyceridaemia and this figure continues to rise, as the prevalence of associated conditions, such as obesity and diabetes, continues to grow. EPANOVA is a pure, free fatty acid form that can provide physicians with an option to effectively manage the condition without dramatically increasing a patient’s pill burden.

The FDA approval was based on data from a clinical development programme that included positive results from the Phase III EVOLVE (EpanoVa fOr Lowering Very High triglyceridEs) trial, which examined the efficacy of EPANOVA in lowering triglycerides and other key lipid parameters in patients with very high triglycerides. The effect of EPANOVA on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined.

As part of AstraZeneca’s commitment to addressing unmet need in cardiovascular disease, the company is continuing to evaluate the clinical profile of EPANOVA. Through a large-scale cardiovascular outcomes trial, STRENGTH (STatin Residual risk reduction with EpaNova in hiGh cardiovascular risk paTients with Hypertriglyceridaemia), AstraZeneca plans to evaluate the safety and efficacy of EPANOVA on cardiovascular outcomes in combination with statin therapy, in patients with mixed dyslipidaemia who are at increased risk of cardiovascular disease. AstraZeneca also plans to pursue the development of a fixed dose combination of EPANOVA with a statin and plans to file for regulatory approval in other markets for the severe hypertriglyceridaemia indication.

(责任编辑:yangsumin)

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