The purpose of this study is to evaluate the role of coronary CT angiogram (CCTA) as a superior guide for the assessment of coronary artery plaque and guiding treatment decisions. The investigators also assess the impact of preventive cardiovascular drugs on the plaque to improve patient outcomes. Participants aged 18-80 years, at intermediate or high-risk for coronary artery disease, with non-obstructive plaque on initial CCTA, will be enrolled in this study. They will be randomized into Standard of Care (SOC) vs. Aggressive Therapy (AT) groups. Both groups will undergo dietary and lifestyle interventions. Follow-up will consist of blood tests and clinic visits at baseline, 9 months, and 18 months. The second CCTA will be performed at 18 months to assess the change in plaque burden, characteristics, ischemia and pericoronary/epicardial fat.

开始日期2024-03-01

申办/合作机构

University of Louisville

NL-OMON51414 / Recruiting临床2期

IcoSApent ethyL to slow down aortic VAlve stenosis proGrEssion - SALVAGE

开始日期2023-06-07

申办/合作机构-

NCT06466278 / Recruiting临床2期IIT

IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion

This study invastigates the effect of icosapent ethyl in patients with aortic valve stenosis.

开始日期2023-06-01

申办/合作机构-

100 项与二十碳五烯酸乙酯相关的临床结果

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100 项与二十碳五烯酸乙酯相关的转化医学

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100 项与二十碳五烯酸乙酯相关的专利（医药）

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755

项与二十碳五烯酸乙酯相关的文献（医药）

2024-03-01·Annals of vascular surgery

Update About the Management of Low-Density Lipoprotein Cholesterol and Hypertriglyceridemia in Lower Extremity Peripheral Artery Disease Patients: Consensus of the French Society of Vascular Medicine and the French Society for Vascular and Endovascular Surgery

Article

作者: Pernod, Gilles ; Gaertner, Sébastien ; Ezzaki, Khalil ; Lejay, Anne ; Picquet, Jean ; Tribout, Laurent ; Boge, Gudrun ; Chleir, Franck ; Magnou, Betty ; Loric, Tiphanie ; Lanéelle, Damien ; Mounier-Vehier, Claire ; Tissot, Anne ; Hertault, Adrien ; Feugier, Patrick ; Behar, Thomas ; Moukarzel, Alain ; Lacroix, Philippe ; Zarca, Charles ; Nasr, Bahaa ; Kaladji, Adrien ; Brisot, Dominique ; Soudet, Simon ; Gaudout, Céline ; Elias, Marie ; Zuber, Anne ; Bérard, Xavier ; Detriché, Grégoire ; Wautrecht, Jean-Claude ; Laffont, Joëlle ; Maillard, Jean-Patrick ; Fiori, Sandrine ; Georg, Yannick ; Bura-Rivière, Alessandra ; Madika, Anne-Laure ; Chakfé, Nabil ; Perez-Martin, Antonia ; Gaillard, Catherine ; Sabatier, Jean ; Nelzy, Marie-Line ; Mahé, Guillaume ; Laroche, Jean-Pierre ; Le Hello, Claire ; Bonnin, Christophe ; Phelipot, Jacques-Yves ; Goueffic, Yann ; Choquenet, Clarisse ; Nicolini, Philippe ; Coscas, Raphael ; Constans, Joël ; Jean-Baptiste, Elixène ; Miserey, Gilles ; Malloizel-Delaunay, Julie ; Breteau, Christophe ; Gauthier, Charles-Emmanuel ; Sprynger, Muriel

BACKGROUND:

A French intersociety consensus on behalf the Société Française de Médecine Vasculaire and the Société de Chirurgie Vasculaire et Endovasculaire was proposed in 2021 for the management of patients with lower extremity peripheral artery disease (LEAD). Recent studies have been published and an update of this consensus about the management of low-density lipoprotein cholesterol (LDLc) and hypertriglyceridemia was required.

METHODS:

A steering committee of 12 vascular physicians and surgeons defined questions of interest about LDLc and hypertriglyceridemia management. A French expert panel voted the proposals. Consensus was considered to have been achieved if more than 80% of the responses corresponded to either "Agreement" or "Disagreement".

RESULTS:

Among the 56 experts who were asked to participate, 46 (82%) accepted. After the first round of the Delphi procedure, the 4 proposals reached consensus. The following suggestions and recommendations were approved: 1. For LEAD patients treated by the highest tolerated statin dose ± ezetimibe and who have an LDLc ≥0.70 g/L, we recommend adding a proprotein convertase subtilisin/kexin type 9 inhibitor. 2. For LEAD patients treated by statin and who have elevated triglyceride level between ≥150 mg/dL and ≤500 mg/dL, we suggest adding Icosapent Ethyl. 3. Before adding Icosapent Ethyl in LEAD patients treated with statin, we suggest looking for symptoms that may suggest atrial fibrillation. 4. For LEAD patients treated by Icosapent Ethyl and who have symptoms that suggest atrial fibrillation, we recommend performing an electrocardiogram.

CONCLUSIONS:

This update will help clinicians to improve LEAD patient management.

2024-02-07·European heart journal

Icosapent ethyl for hypertriglyceridaemia and atherosclerosis: greater RESPECT for increased therapeutic use

Article

作者: Gaba, Prakriti ; Bhatt, Deepak L ; Boden, William E

2024-01-02·Journal of the American Heart Association

Cost‐Effectiveness of Icosapent Ethyl in REDUCE‐IT USA: Results From Patients Randomized in the United States

Article

作者: Bellows, Brandon K ; Bhatt, Deepak L ; Miller, Michael ; Kolm, Paul ; Ballantyne, Christie M ; Boden, William E ; Bress, Adam P ; Brinton, Eliot A ; Jacobson, Terry A ; Philip, Sephy ; Derington, Catherine G ; Tardif, Jean-Claude ; Weintraub, William S ; Steg, Gabriel ; Zhang, Zugui ; Dolman, Sarahfaye

Background:

In 3146 REDUCE‐IT USA (Reduction of Cardiovascular Events With Icosapent Ethyl Intervention Trial USA) participants, icosapent ethyl (IPE) reduced first and total cardiovascular events by 31% and 36%, respectively, over 4.9 years of follow‐up.

Methods and Results:

We used participant‐level data from REDUCE‐IT USA, 2021 US costs, and IPE costs ranging from $4.59 to $11.48 per day, allowing us to examine a range of possible medication costs. The in‐trial analysis was participant‐level, whereas the lifetime analysis used a Markov model. Both analyses considered value from a US health sector perspective. The incremental cost‐effectiveness ratio (incremental costs divided by incremental quality‐adjusted life‐years) of IPE compared with standard care (SC) was the primary outcome measure. There was incremental gain in quality‐adjusted life‐years with IPE compared with SC using in‐trial (3.28 versus 3.13) and lifetime (10.36 versus 9.83) horizons. Using an IPE cost of $4.59 per day, health care costs were lower with IPE compared with SC for both in‐trial ($29 420 versus $30 947) and lifetime ($216 243 versus $219 212) analyses. IPE versus SC was a dominant strategy in trial and over the lifetime, with 99.7% lifetime probability of an incremental cost‐effectiveness ratio <$50 000 per quality‐adjusted life‐year gained. At a medication cost of $11.48 per day, the cost per quality‐adjusted life‐year gained was $36 208 in trial and $4135 over the lifetime.

Conclusions:

In this analysis, at $4.59 per day, IPE offers better outcomes than SC at lower costs in trial and over a lifetime and is cost‐effective at $11.48 per day for conventional willingness‐to‐pay thresholds. Treatment with IPE should be strongly considered in US patients like those enrolled in REDUCE‐IT USA.

Registration:

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01492361.

150

项与二十碳五烯酸乙酯相关的新闻（医药）

2024-07-01

·信狐药迅

铂生卓越国内首个干细胞治疗新药艾米迈托赛注射液提交上市申请|新受理（6.24-6.30）

本周药品注册受理数据，分门别类呈现，一目了然。(6.24-6.30）新药上市申请药品名称企业注册分类受理号艾米迈托赛注射液铂生卓越生物科技(北京)有限公司1CXSS2400062 新药临床申请药品名称企业注册分类受理号注射用HRS-2183江苏恒瑞医药股份有限公司1CXHL2400635YY2201片江苏亚尧生物科技有限公司1CXHL2400632YY2201片江苏亚尧生物科技有限公司1CXHL2400631注射用甲磺酸普依司他成都赜灵生物医药科技有限公司1CXHL2400630HW071021片武汉人福创新药物研发中心有限公司1CXHL2400628HW071021片武汉人福创新药物研发中心有限公司1CXHL2400627YMP透皮贴剂北京泰德制药股份有限公司2.1CXHL2400638YMP透皮贴剂北京泰德制药股份有限公司2.1CXHL2400637YMP透皮贴剂北京泰德制药股份有限公司2.1CXHL2400636注射用HY-022619合肥医工医药股份有限公司2.1CXHL2400629RHYK2017仁合益康集团有限公司2.2CXHL2400634RHYK2017仁合益康集团有限公司2.2CXHL2400633QLM1016齐鲁制药有限公司2.2CXHL2400642QLM1016齐鲁制药有限公司2.2CXHL2400641QLM1016齐鲁制药有限公司2.2CXHL2400640QLM1016齐鲁制药有限公司2.2CXHL2400639LN016缓释凝胶上海惠永制药有限公司2.2CXHL2400626米诺地尔泡沫剂辰光(天津)制药有限公司3CYHL2400133格隆溴铵新斯的明注射液成都诺和晟鸿生物制药有限公司3CYHL2400130奥氮平萨米多芬片齐鲁制药有限公司3CYHL2400129奥氮平萨米多芬片齐鲁制药有限公司3CYHL2400128奥氮平萨米多芬片齐鲁制药有限公司3CYHL2400127奥氮平萨米多芬片齐鲁制药有限公司3CYHL2400126琥珀酰明胶注射液南京正大天晴制药有限公司4CYHL2400132琥珀酰明胶电解质醋酸钠注射液南京正大天晴制药有限公司4CYHL2400131注射用IAE0972盛禾(中国)生物制药有限公司1CXSL2400418TQC2938注射液正大天晴药业集团南京顺欣制药有限公司1CXSL2400417LY3540378注射液礼来苏州制药有限公司1CXSL2400415注射用MSC303北京天广实医药科技有限公司1CXSL2400416SYS6010石药集团巨石生物制药有限公司1CXSL2400414重组抗PD-1全人源单抗注射液石药集团中奇制药技术(石家庄)有限公司1CXSL2400413注射用BAT8006百奥泰生物制药股份有限公司1CXSL2400411CM313(SC)注射液康诺亚生物医药科技(成都)有限公司1CXSL2400410静注人免疫球蛋白(pH4)成都蓉生药业有限责任公司3.2CXSL2400412度普利尤单抗注射液百奥泰生物制药股份有限公司3.3CXSL2400409 仿制药申请药品名称企业注册分类受理号维生素B6注射液海南皇隆制药股份有限公司3CYHS2401955维生素B6注射液华夏生生药业(北京)有限公司3CYHS2401954布美他尼注射液海南卓科制药有限公司3CYHS2401952布美他尼注射液海南卓科制药有限公司3CYHS2401951布美他尼注射液四川奇裕医药科技有限公司3CYHS2401950碳酸镧颗粒福建博悦医药科技有限公司3CYHS2401942碳酸镧颗粒福建博悦医药科技有限公司3CYHS2401941硫辛酸片江苏万禾制药有限公司3CYHS2401935硫辛酸片江苏万禾制药有限公司3CYHS2401934盐酸溴己新口服溶液福元药业有限公司3CYHS2401932盐酸左西替利嗪口服溶液海南斯达制药有限公司3CYHS2401918盐酸左西替利嗪口服溶液海南斯达制药有限公司3CYHS2401917酒石酸美托洛尔注射液北京远方通达医药技术有限公司3CYHS2401933布美他尼注射液扬州中宝药业股份有限公司3CYHS2401931琥乙红霉素片呋欧医药科技(湖州)有限公司3CYHS2401930吸入用盐酸丙卡特罗溶液南京恒道医药科技股份有限公司3CYHS2401928吸入用盐酸丙卡特罗溶液南京恒道医药科技股份有限公司3CYHS2401927依巴斯汀口服溶液北京民康百草医药科技有限公司3CYHS2401926福多司坦口服溶液太康海恩药业有限公司3CYHS2401923福多司坦口服溶液太康海恩药业有限公司3CYHS2401922醋酸钙口服溶液河南华雒康润药业有限公司3CYHS2401921顺铂注射液华夏生生药业(北京)有限公司3CYHS2401913盐酸曲唑酮片福安药业集团宁波天衡制药有限公司3CYHS2401910盐酸曲唑酮片福安药业集团宁波天衡制药有限公司3CYHS2401909叶酸片河北爱普制药有限公司3CYHS2401903硫酸阿米卡星注射液湖南柏齐鹤药物研发有限公司3CYHS2401897羧甲司坦口服溶液保定爱晖药业有限公司3CYHS2401912注射用哌拉西林钠东阳祥昇医药科技有限公司3CYHS2401889注射用哌拉西林钠东阳祥昇医药科技有限公司3CYHS2401888注射用哌拉西林钠东阳祥昇医药科技有限公司3CYHS2401887昂丹司琼口溶膜杭州沐源生物医药科技有限公司3CYHS2401886昂丹司琼口溶膜杭州沐源生物医药科技有限公司3CYHS2401885吡格列酮二甲双胍片浙江易泽达医药科技有限公司3CYHS2401882法莫替丁注射液重庆市义力医药科技有限公司3CYHS2401875注射用拉氧头孢钠南京丰恺思药物研发有限公司3CYHS2401874法莫替丁注射液江苏神龙药业有限公司3CYHS2401873卡络磺钠注射液国药集团国瑞药业有限公司3CYHS2401872复合磷酸氢钾注射液山东华鲁制药有限公司3CYHS2401893沙格列汀二甲双胍缓释片山东淄博新达制药有限公司4CYHS2401959沙格列汀二甲双胍缓释片山东淄博新达制药有限公司4CYHS2401958美沙拉秦肠溶片华东医药(西安)博华制药有限公司4CYHS2401957盐酸贝尼地平片新乡市常乐制药有限责任公司4CYHS2401956阿奇霉素干混悬剂浙江中同药业有限公司4CYHS2401953醋酸阿托西班注射液湖南科伦制药有限公司4CYHS2401944醋酸阿托西班注射液湖南科伦制药有限公司4CYHS2401943醋酸来法莫林片住友制药(苏州)有限公司4CYHS2401945盐酸奥布卡因滴眼液南京恒道医药科技股份有限公司4CYHS2401940硫酸艾沙康唑胶囊杭州沐源生物医药科技有限公司4CYHS2401939盐酸阿莫罗芬搽剂浙江恒研医药科技有限公司4CYHS2401938卡贝缩宫素注射液云南药科院生物医药股份有限公司4CYHS2401937双氯芬酸二乙胺乳胶剂江苏万高药业股份有限公司4CYHS2401936缬沙坦片深圳奥萨制药有限公司4CYHS2401949富马酸伏诺拉生片广东东阳光药业股份有限公司4CYHS2401948富马酸伏诺拉生片广东东阳光药业股份有限公司4CYHS2401947依折麦布阿托伐他汀钙片(I)山西德元堂药业有限公司4CYHS2401946盐酸戊乙奎醚注射液成都华宇制药有限公司4CYHS2401929盐酸左西替利嗪口服滴剂安徽康融药业有限公司4CYHS2401925硫酸氨基葡萄糖胶囊济南高华制药有限公司4CYHS2401924布洛芬混悬液四川益生智同医药生物科技发展有限公司4CYHS2401920布洛芬混悬液北京韩美生物科技有限公司4CYHS2401919亚叶酸钙注射液河北千康医药科技有限责任公司4CYHS2401916盐酸达泊西汀片烟台鲁银药业有限公司4CYHS2401914比拉斯汀片浙江诺得药业有限公司4CYHS2401911阿法骨化醇软胶囊北京万辉双鹤药业有限责任公司4CYHS2401908罗沙司他胶囊安徽省先锋制药有限公司4CYHS2401907罗沙司他胶囊安徽省先锋制药有限公司4CYHS2401906盐酸纳呋拉啡口腔崩解片湖南科伦制药有限公司4CYHS2401905甲硝唑凝胶湖南及正医药科技有限公司4CYHS2401904托吡酯片四川科瑞德制药股份有限公司4CYHS2401902托吡酯片四川科瑞德制药股份有限公司4CYHS2401901盐酸奥洛他定滴眼液江苏福邦药业有限公司4CYHS2401900盐酸奥洛他定滴眼液浙江赛默制药有限公司4CYHS2401899普拉洛芬滴眼液山东如至生物医药科技有限公司4CYHS2401898复方氨基酸(16AA)/葡萄糖(12.6%)电解质注射液山东齐都药业有限公司4CYHS2401895复方氨基酸(16AA)/葡萄糖(12.6%)电解质注射液山东齐都药业有限公司4CYHS2401894地夸磷索钠滴眼液中国大冢制药有限公司4CYHS2401915莫匹罗星软膏河北新张药股份有限公司4CYHS2401896注射用泮托拉唑钠湖北长联杜勒制药有限公司4CYHS2401890吸入用乙酰半胱氨酸溶液山东禾琦制药有限公司4CYHS2401884阿达帕林凝胶华润三九医药股份有限公司4CYHS2401883阿达帕林凝胶山东良福制药有限公司4CYHS2401880注射用盐酸万古霉素深圳华润九新药业有限公司4CYHS2401879磷酸芦可替尼片江西科睿药业有限公司4CYHS2401878米拉贝隆缓释片成都康弘药业集团股份有限公司4CYHS2401877二甲双胍维格列汀片(II)仁合益康集团有限公司4CYHS2401876他氟前列素滴眼液湖北民康药业集团有限公司4CYHS2401892二十碳五烯酸乙酯软胶囊杭州中美华东制药有限公司4CYHS2401891盐酸纳呋拉啡口腔崩解片湖北民康制药有限公司4CYHS2401881注射用特立帕肽信立泰(苏州)药业有限公司3.4CXSS2400061 进口申请药品名称企业注册分类受理号盐酸阿思尼布片Novartis Pharma Schweiz AG2.4JXHS2400043注射用塞替派Esteve Pharmaceuticals GmbH5.2JYHS2400035注射用A型肉毒毒素Huons BioPharma Co., Ltd.3.4JXSS2400051TAK-279片Takeda Development Center Americas, Inc.1JXHL2400146ASP1570片Astellas Pharma Global Development, Inc.1JXHL2400150ASP1570片Astellas Pharma Global Development, Inc.1JXHL2400149布地奈德硫酸沙丁胺醇吸入气雾剂AstraZeneca Pharmaceuticals LP2.2JXHL2400148盐酸阿来替尼胶囊F.Hoffmann-La Roche Ltd.2.4JXHL2400145布地奈德硫酸沙丁胺醇吸入气雾剂AstraZeneca Pharmaceuticals LP5.1JXHL2400147DS-1062aASTRAZENECA AB1JXSL2400117 中药相关申请药品名称企业注册分类受理号开心散上海和黄药业有限公司3.1CXZS2400024苓桂术甘汤颗粒浙江康恩贝制药股份有限公司3.1CXZS2400023天川颗粒山东齐都药业有限公司1.1CXZL2400036八味龙钻颗粒广西中医药大学百年乐制药有限公司1.1CXZL2400035 不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市细胞疗法临床申请ASH会议

2024-06-27

·生物探索

Nat Metab | 艾玎/朱毅/孙金鹏发现多不饱和脂肪酸对动脉粥样硬化保护作用的潜在机理

引言 Omega-3多不饱和脂肪酸(ω-3 PUFAs)与潜在的心血管益处有关，部分归因于其生物活性代谢物。然而，造成这些优势的潜在机制还没有被完全理解。之前报道了来自二十碳五烯酸(EPA)的细胞色素P450途径的代谢物介导ω-3 PUFAs的动脉粥样硬化保护作用。 2024年6月21日，天津医科大学艾玎、朱毅及山东大学孙金鹏共同通讯在Nature Metabolism 在线发表题为“The sphingosine-1-phosphate receptor 1 mediates the atheroprotective effect of eicosapentaenoic acid”的研究论文，该研究发现内皮细胞(ECs)中的17,18-环氧二碳四烯酸(17,18-EEQ)及其受体鞘氨醇-1-磷酸受体1 (S1PR1)可以抑制振荡剪切应力或肿瘤坏死因子-α诱导的内皮细胞活化。值得注意的是，在内皮细胞S1PR1缺乏的雄性小鼠中，17,18-EEQ和纯化EPA的动脉粥样硬化保护作用被绕过。在机制上，17,18-EEQ的抗炎作用依赖于钙释放介导的内皮型一氧化氮合酶(eNOS)的激活，而eNOS的激活在抑制S1PR1或Gq信号传导时被消除。此外，17,18-EEQ通过与Lys34Nter的极性相互作用变构调节S1PR1的构象。最后，含有高纯度和稳定的EPA乙酯的处方药Vascepa通过17,18-EEQ-S1PR1途径在雄性和雌性小鼠中发挥心血管保护作用。总之，该研究结果表明，17,18-EEQ的抗炎作用涉及激活ECs中的S1PR1-Gq-Ca2+ -eNOS轴，为动脉粥样硬化提供了潜在的治疗靶点。心血管疾病仍然是一个主要的全球健康问题，促使对潜在的预防和治疗战略进行广泛的研究。ω-3 PUFAs，特别是EPA和二十二碳六烯酸(DHA)，因其潜在的心血管益处而受到相当多的关注。食用深海鱼或鱼油，已知是ω-3 PUFAs的丰富来源，与降低心血管终点事件的发生率有很强的相关性。然而，研究ω-3 PUFAs对心血管结果影响的临床试验结果相互矛盾，导致其真正功效的不确定性。ω-3 PUFAs发挥其心血管作用的潜在机制尚未完全解决。 G蛋白偶联受体(GPCRs)是人体组织中表达的最大的膜受体家族，通过检测细胞外配体和启动细胞内信号级联反应，在调节广泛的生理反应中发挥关键作用。近年来，作为人类疾病的潜在治疗靶点，GPCRs引起了越来越多的关注。值得注意的是，一个显著的发现是通过特定的脂肪酸代谢物识别和激活许多GPCRs，从而通过第二信使或阻滞蛋白介导的机制调节细胞内信号通路。例如，包括GPR41、GPR43、GPR84、GPR40和GPR120在内的几种GPCRs已显示出对脂肪酸刺激的反应性。此外，ARA衍生的代谢物，如前列腺素，通过环加氧酶途径产生，导致多种脂质介质的产生，包括PGE2、PGF2α和PGD2。这些代谢物依次选择性地激活特定受体，如EP、FP和PGD受体。然而，EPA和DHA及其各自的代谢物通过与细胞特异性GPCRs结合而作为信号分子发挥作用的程度仍有待充分阐明。 17,18-EEQ介导的抗炎作用机制（Credit: Nature Metabolism）该研究发现S1PR1是17,18-EEQ的受体，并证明17,18-EEQ通过偏向的S1PR1-Gq-Ca2+-eNOS信号抑制内皮活化和动脉粥样硬化。分子对接证实，17,18-EEQ通过与Lys34Nter形成极性相互作用，正极激活S1PR1。S1PR1缺陷小鼠没有表现出17,18-EEQ介导的动脉粥样硬化进展的减少。此外，我们还通过实验验证了Vascepa的心血管保护作用，Vascepa是一种含有高纯度和稳定的EPA乙酯的处方药，已被FDA批准用于降低心血管风险。总之，该研究揭示了S1PR1作为一种新发现的17,18-EEQ受体，选择性激活Gq-Ca2+ -eNOS信号以抑制血管内皮的激活。这些发现有助于更好地理解17,18-EEQ对血管内皮细胞保护作用的分子机制。参考文献 https://www-nature-com.libproxy1.nus.edu.sg/articles/s42255-024-01070-3 责编|探索君排版|探索君文章来源|“iNature” End 往期精选围观一文读透细胞死亡(Cell Death) | 24年Cell重磅综述（长文收藏版）热文 Cell | 是什么决定了细胞的大小？热文 Nature | 2024年值得关注的七项技术热文 Nature | 自身免疫性疾病能被治愈吗？科学家们终于看到了希望热文 CRISPR技术进化史 | 24年Cell综述

2024-06-26

·FiercePharma

After stock crash and staff cuts, Amarin wins bid to revive Vascepa patent lawsuit

Amarin's shares have lost more than 95% of their value since the start of 2020. The loss of patent protection on Amarin’s sole commercial product Vascepa in 2020 has led to a roller coaster ride for the Dublin-based company over the past few years. But, now, the drugmaker is getting a fresh shot to challenge Hikma Pharmaceuticals’ generic version of its fish-oil-derived heart med in the lower courts. Tuesday, the U.S. Court of Appeals for the Federal Circuit revived (PDF) Amarin’s Vascepa patent lawsuit against generics giant Hikma. “Because Amarin’s allegations against Hikma plausibly state a claim for induced infringement, we reverse,” the court wrote in a legal filing this week. The case comes down to so-called “skinny labels,” which allow generic drug makers to get their copycat medicines approved for one or several—but not necessarily all—approved indications of their brand-name counterparts. The practice has proven controversial in Amarin and Hikma’s case, plus at least one other lawsuit involving Teva and GSK. Vascepa, also known as icosapent ethyl, won its first approval to reduce triglyceride levels in adults with severe hypertriglyceridemia in 2012. In 2019, the drug snagged a second FDA nod to reduce cardiovascular risks in adults with certain risk factors. Amarin originally sued Hikma in Delaware in 2020 after the generics maker in 2016 filed for approval of a copycat version of Vascepa that only included the severe hypertriglyceridemia nod and not the label language around cardio risks. The FDA approved Hikma’s Vascepa generic with a “skinny label” in May of 2020, court documents show. The appeals court this week ruled that Hikma’s generic label, press releases and marketing work may have prompted doctors to prescribe the copycat in violation of Amarin’s patents. The court specifically noted that Hikma publicly referred to its product as “generic Vascepa” without acknowledging the med’s label limitations. In turn, doctors were likely encouraged to prescribe the cheaper generic med for Vascepa’s full range of approved uses, the appeals court ruled. Amarin and Hikma did not immediately respond to Fierce Pharma’s request for comment. Chad Landmon, chair of the IP and FDA practice groups at law firm Axinn, Veltrop & Harkrider, noted that the Amarin-Hikma case is unusual because it concerns a launched generic, whereas most IP litigation occurs before approval and rollout. “I’m sure the decision is obviously a disappointment to Hikma, but I think also the generic and biosimilar industries probably are a little disappointed,” he told Fierce in an interview. Ever since Amarin’s U.S. patent loss on Vascepa, the company has been striving to make the most of the European market. Meanwhile, the market shift has resulted in much executive turnover and layoffs at the Irish company. Last summer, Amarin revealed that it would lay off its entire U.S. sales force and reduce its non-sales staff by 30%—amounting to roughly 120 out of 385 employees. The company also announced the appointment of Patrick Holt as its new CEO. Earlier this month, Holt said he was headed for the exit. Amarin’s new CEO will be Aaron Berg, who briefly served as Amarin’s interim chief executive last year following the abrupt departure of helmsman Karim Mikhail. Amarin's shares have lost more than 95% of their value since the start of 2020. Its shares haven't much budged in response to the latest legal development.

高管变更上市批准专利侵权生物类似药

100 项与二十碳五烯酸乙酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01892	二十碳五烯酸乙酯	C10AX	DB08887

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
心血管疾病	美国	Amarin Pharmaceuticals Ireland Ltd.	2019-12-13
高甘油三酯血症	美国	Amarin Pharmaceuticals Ireland Ltd.	2012-07-26
动脉硬化闭塞症	日本	Mochida Pharmaceutical Co., Ltd.	1998-10-15
高脂血症	日本	Mochida Pharmaceutical Co., Ltd.	1994-10-05

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
霍奇金淋巴瘤	临床3期	美国	Amarin Neuroscience Ltd.	2005-09-01
霍奇金淋巴瘤	临床3期	加拿大	Amarin Neuroscience Ltd.	2005-09-01
亨廷顿舞蹈病	临床3期	美国	Amarin Neuroscience Ltd.	2005-09-01
亨廷顿舞蹈病	临床3期	加拿大	Amarin Neuroscience Ltd.	2005-09-01
非酒精性脂肪性肝炎	临床2期	美国	Mochida Pharmaceutical Co., Ltd.	2010-06-01
非酒精性脂肪性肝炎	临床2期	波多黎各	Mochida Pharmaceutical Co., Ltd.	2010-06-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01492361 (REDUCE-IT, GlobeNewswire) 人工标引	N/A	心血管疾病	-	Icosapent Ethyl (IPE) (Lp(a) ≥50 mg/dL)	鹹鹽壓鹹艱願簾襯憲廠(膚積窪構築齋膚鏇鏇觸) = 範餘顧網觸糧鏇窪廠積積蓋遞餘遞構餘繭製願 (糧遞遞蓋壓廠繭蓋憲餘 ) 更多	积极	2024-04-06
				Icosapent Ethyl (IPE) (Lp(a) <50 mg/dL)	鹹鹽壓鹹艱願簾襯憲廠(膚積窪構築齋膚鏇鏇觸) = 醖築鹽齋鏇鏇鬱艱鹽淵積蓋遞餘遞構餘繭製願 (糧遞遞蓋壓廠繭蓋憲餘 ) 更多
NCT01492361 (REDUCE-IT USA, Pubmed)	临床3期	-	3,146	Icosapent Ethyl	廠餘觸壓鹽齋窪鹽餘窪(淵衊鏇願衊鏇觸襯築願) = 顧鑰蓋製鑰糧蓋觸齋築獵繭鏇糧製餘餘淵壓襯 (積網淵壓製網襯餘築淵 ) 更多	-	2024-01-02
NCT01492361 (REDUCE-IT, GlobeNewswire) 人工标引	临床3期	心血管疾病 \| 代谢综合征	2,866	VASCEPA	選廠築遞鏇鬱鬱窪鬱構(艱積網蓋壓遞顧願觸醖): relative risk reduction = 29, P-Value = <0.0001; absolute risk reduction = 5.9 更多	积极	2023-11-12
				placebo
NCT01492361 (REDUCE-IT, Pubmed)	临床3期	代谢综合征	8,179	Icosapent ethyl 4 g/day	鹹網積鬱鏇構製範顧製(廠壓積夢構築衊膚選糧) = 構窪鹹範鹽製廠製憲鑰壓壓艱遞鹽顧衊窪壓繭 (蓋壓簾觸製齋顧艱構築 )	积极	2023-11-03
REDUCE-IT (ESC2023)	N/A	-	-	Icosapent ethyl	艱願餘襯襯鑰廠鑰築製(製壓遞艱範廠選網觸蓋) = 築憲膚鹹衊築簾鬱鹽範範衊構鬱憲鏇齋衊築簾 (觸廠選繭鹽願廠艱積鏇, 1.8 ~ 8.7)	-	2023-08-27
				Placebo	艱願餘襯襯鑰廠鑰築製(製壓遞艱範廠選網觸蓋) = 繭遞蓋築遞齋膚願衊襯範衊構鬱憲鏇齋衊築簾 (觸廠選繭鹽願廠艱積鏇, 1.9 ~ 9.4)
NCT01492361 (REDUCE-IT, Pubmed)	临床3期	心房颤动	8,179	Icosapent Ethyl	鑰夢衊遞鬱餘壓積觸網(壓願餘鹹艱夢膚襯齋遞) = 鏇齋夢顧夢餘憲製衊壓範網製衊壓淵壓窪製膚 (襯獵窪夢簾製鏇鑰淵鹽 )	-	2023-02-21
				Placebo	鑰夢衊遞鬱餘壓積觸網(壓願餘鹹艱夢膚襯齋遞) = 範築選襯鬱蓋壓襯壓選範網製衊壓淵壓窪製膚 (襯獵窪夢簾製鏇鑰淵鹽 )
NCT04221217 (Pubmed) 人工标引	临床3期	高甘油三酯血症	122	MND-2119 (2 g/day)	淵壓鏇願繭築醖簾餘憲(築醖夢製簾遞餘鑰繭製) = 衊製夢鏇糧觸製網餘蓋願築選膚壓窪願構願窪 (鏇範醖繭憲網範觸餘製 ) 更多	积极	2022-09-11
				MND-2119 (4 g/day)	淵壓鏇願繭築醖簾餘憲(築醖夢製簾遞餘鑰繭製) = 選鏇積鏇膚壓齋繭膚範願築選膚壓窪願構願窪 (鏇範醖繭憲網範觸餘製 ) 更多
NCT01492361 (REDUCE-IT, Pubmed)	临床3期	高甘油三酯血症 \| 心血管疾病	8,179	Icosapent ethyl	製襯鏇憲鏇廠繭範繭願(鬱選淵廠鏇淵壓鏇蓋襯) = there was a slight increase in atrial fibrillation 艱遞鹽積廠鏇網鹽繭艱 (窪鏇壓築淵願醖鏇範夢 ) 更多	积极	2022-05-03
				Placebo
NCT01047683 (CTgov)	临床3期	高甘油三酯血症	229	AMR101 (ethyl icosapentate) - 2 g/day (AMR101 (Ethyl Icosapentate) - 2 g/Day)	衊鹹夢憲遞齋範憲窪窪(鹽鹽齋鏇鏇膚獵齋選築) = 獵餘顧選簾餘蓋醖艱鏇鹽築觸壓窪鏇製鬱鹹構 (衊餘鑰範鬱選窪鏇醖醖, 選網夢艱選淵鏇鹹築範 ~ 積壓窪艱齋壓夢築窪糧) 更多	-	2022-04-25
				AMR101 (ethyl icosapentate) - 4 g/day (AMR101 (Ethyl Icosapentate) - 4 g/Day)	衊鹹夢憲遞齋範憲窪窪(鹽鹽齋鏇鏇膚獵齋選築) = 繭鹹獵獵膚淵遞窪鹽願鹽築觸壓窪鏇製鬱鹹構 (衊餘鑰範鬱選窪鏇醖醖, 製蓋觸選獵鹹齋選製鹹 ~ 淵築簾遞憲艱鏇築餘鑰) 更多
NCT01492361 (REDUCE-IT \| REDUCE-IT PCI \| REDUCE-IT USA \| REDUCE-IT CABG, CTgov)	临床3期	高甘油三酯血症 \| 心血管疾病	8,179	Statin therapy+AMR101 (AMR101)	憲觸窪遞製窪構積構繭(鑰繭繭鹹顧蓋築夢窪網) = 窪觸願醖築醖範鑰醖窪窪醖鹹醖鑰觸鏇鹹襯衊 (範鹹窪窪鹽鹽網憲繭鬱, 壓鹹醖顧壓糧鹹繭醖夢 ~ 憲選醖窪範齋淵齋顧網) 更多	-	2022-04-14
				Statin therapy+Placebo (Placebo)	憲觸窪遞製窪構積構繭(鑰繭繭鹹顧蓋築夢窪網) = 蓋選構鹹築蓋餘觸鏇遞窪醖鹹醖鑰觸鏇鹹襯衊 (範鹹窪窪鹽鹽網憲繭鬱, 襯窪築艱鏇鬱膚鹽糧廠 ~ 鏇繭糧築積衊淵簾積獵) 更多