| 赛诺菲-安万特 (Sanofi-aventis)今天宣布，美国食品与药物管理局(FDA)已经批准了抗凝血的 Lovenox(R)（依诺肝素钠注射液）的补充新药申请 (sNDA)。Lovenox(R) 用于治疗急性 ST 段抬高心肌梗死(STEMI)患者。Lovenox(R)已经显示出可以减少周期性心肌梗塞综合终点的发生率，并可降低接受溶栓治疗、药物治疗或经皮冠状动脉介入治疗(PCI)的急性 STEMI患者的死亡率。 STEMI 是一种严重的心脏病，这种疾病表现为动脉通常完全被血栓所堵塞，累积足够长时间可导致心脏肌肉损坏。 美国食品与药物管理局批准该补充新药申请书的依据是里程碑式的 ExTRACT-TIMI 25 试验（依诺肝素和溶栓灌注法用于治疗急性心肌梗塞，溶栓法治疗心肌梗塞-25研究）成果。参与 ExTRACT-TIMI 25 试验的有20,000多名急性 STEMI 患者。ExTRACT-TIMI 25 试验的结果已经公布在2006年4月6日刊发的《New England Journal of Medicine》（新英格兰医学杂志）上。 ExTRACT-TIMI 25 研究表明，在接受了纤维蛋白溶解治疗的 STEMI 患者中，在三十天的时间里，依诺肝素较普通肝素 (UFH) 可极大地降低这些患者的死亡率和心肌梗塞的复发率，降幅为17%（9.9% 对 12.0%，p 值小于0.001）。与普通肝素相比较的时候依诺肝素显示出来的优点，均可在30内使用经皮冠状动脉介入治疗的随机选择的患者以及采用药物治疗的患者身上看到。采用依诺肝素进行治疗的组别里，30天的重大出血率（包括颅内出血率）为2.1%，而采用普通肝素的组别的重大出血率则为1.4% (p值小于0.001)。采用依诺肝素进行治疗的组别的死亡、非致命性心肌梗塞复发以及非致命性颅内出血（净临床优点的衡量尺度）的30天综合终点率明显低于采用普通肝素的组别（10.1% 对 12.2%，p值小于0.001）。 ExTRACT-TIMI 25 研究的首席研究员、哈佛大学医学院 (Harvard Medical School) 医学教授、布莱根妇女医院 (Brigham and Women's Hospital) Samuel A. Levine 心脏科主管、TIMI Study Groups 高级研究员 Elliott Antman 医学博士表示：“在评估可治疗 STEMI 患者的治疗选择上，此次美国食品与药物管理局对该申请的批准是一个重要的里程碑。有了这一新指示，依诺肝素现在就可以应用到各种急性冠脉综合征的治疗当中。这些病症包括不稳定性心绞痛或非 ST 段抬高心肌梗死 (UA/NSTEMI) 以及 STEMI。” 赛诺菲-安万特还在欧洲国家（包括法国、德国、英国、意大利和西班牙）已经提交了关于 STEMI 适应症的档案。 冠状动脉疾病和急性冠脉综合征简介 冠状动脉疾病 (CAD) 是全球最常见的一种心脏病，同时也是全世界最严重的健康问题。每年冠状动脉疾病夺去了大约1700万人的性命，也就是说全球每三个死亡的人当中就有一个死于冠状动脉疾病。美国心脏协会表示，超过1300万美国人都有过冠状动脉疾病病史，有750万人患有急性心脏病。 急性冠脉综合征 (ACS) 是一个总称，用于形容因冠状动脉狭窄而导致的一组临床症状以及伴随有急性心肌局部缺血的任何类型的临床症状。急性心肌局部缺血是由冠状动脉疾病导致的心肌对氧的供求失衡所造成的。 所有急性冠脉综合征都需要进行立即治疗。其治疗方法是多层面的，旨在尝试保护受损心肌免受进一步的损害、恢复动脉中的血液流动以及减轻心脏对氧的需求。在急诊室，首要目标是迅速鉴别 MI (STEMI) 患者，排除胸痛的其他原因，并把患者按照风险高低划分组别，提供适宜的治疗，以便把对心肌的损伤和心肌局部缺血降低到最小程度。 血液回流到心脏（灌注法）可以通过使用某些药物（纤维蛋白溶解药）、摧毁血栓或通过手术（经皮冠状动脉介入治疗）进行治疗来实现。治疗急性冠脉综合征的药物选择包括：使用抗血小板药物来防止血小板粘合在一起从而形成血栓，使用抗凝血剂来阻止血栓。抗凝血剂可防止血栓进一步恶化以及新血栓的形成，但是抗凝血剂却不能够溶解血栓。 Lovenox(R) 简介 Lovenox(R) 是一种抗血栓形成药剂中的独特化学实体，是一种低分子肝素 (LMWH)。作为全球最畅销的低分子肝素，Lovenox(R) 可通过肝磷脂苄基酯的碱降解而得到，大约是普通肝素分子大小的三分之一。Lovenox(R) 是被人们研究最为广泛的低分子肝素，15年来治疗了96个国家的1.3亿名患者。 Lovenox(R) 在美国获批用于与阿斯匹林一起预防不稳定心绞痛和非 Q 段（非 ST 抬高心肌梗死）的局部缺血并发症，用于治疗深静脉血栓 (DVT)。深静脉血栓可能导致肺动脉栓塞 (PE)，与苄丙酮香豆素钠 (warfarin sodium) 一起治疗急性深静脉血栓住院患者（无论有无肺动脉栓塞），以及与苄丙酮香豆素钠一起治疗无肺动脉栓塞的急性深静脉血栓门诊病人。其中的预防适用于可能会患得血栓并发症的作过腹部手术的患者、做过髋关节置换术的患者（正在住院治疗或住院治疗之后）以及患得急性病期间移动严重受限导致可能会患得血栓并发症的医疗患者。 深静脉血栓和肺动脉栓塞简介 深静脉血栓引起了身体深静脉内的血栓的形成，常常发生在较低的末端。每年，美国有多达两百万人患得深静脉血栓。肺动脉栓塞是深静脉血栓的一种严重并发症，有时可导致人丧命，每年美国有约300,000人死于这种并发症，多于乳腺癌和艾滋病致死人数的总和。 深静脉血栓潜在的主要问题是阻碍了涉及到的深静脉内的血液流动，这是由于在深静脉内形成了血栓。血液流动不畅可导致急性的腿疼和肿胀等症状。血栓的部分从深静脉的形成位置被驱逐出来，随着血液流动而在血管中行走，最后抵达肺部并留在那里的时候便形成了肺动脉栓塞。有很多与肺动脉栓塞有关的症状，但是最常见的包括呼吸急促以及在深呼吸时侧胸疼痛加剧。有很多可导致深静脉血栓的常见的风险因素，其中包括长期不能移动、大型手术、慢性病、癌症、年龄大于40岁、外伤、口服避孕药、怀孕以及产后。 深静脉血栓的治疗办法包括在某些危险疾病情况下进行预防以及对确诊的深静脉血栓患者进行急性治疗。对深静脉血栓的治疗有几种治疗办法，其中包括提早活动、抗血栓压力带或器械、腿部压力设备以加强血液流动，还有抗凝血剂和/或血液稀释药物。就与深静脉血栓有关的迹象和症状向您的医疗保健专业人士进行咨询是非常重要的。
- Lovenox(R) is the Low-Molecular Weight Heparin, Approved in the United States for the Broadest Range of Indications Sanofi-aventis announced today that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the anticoagulant Lovenox(R) (enoxaparin sodium injection) for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI). Lovenox(R) has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute STEMI receiving thrombolysis and being managed medically or with Percutaneous Coronary Intervention (PCI). STEMI is a severe type of heart attack in which an artery is generally completely blocked by blood clot for sufficient time causing heart muscle damage. The FDA approval is based on the results of the landmark ExTRACT-TIMI 25 trial (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial InfarCtion Treatment, Thrombolysis In Myocardial Infarction - 25 Study), which included more than 20,000 acute STEMI patients and the results of which were published in the April 6, 2006 edition of the New England Journal of Medicine. The ExTRACT-TIMI 25 study showed that in patients with STEMI treated with fibrinolysis, enoxaparin significantly reduced the rate of death or recurrent infarction at 30 days by 17% vs. unfractionated heparin (UFH) (9.9% vs. 12.0% p<0.001). This benefit of enoxaparin, as compared to UFH, was observed both in patients who underwent percutaneous coronary intervention within 30 days after randomization or who where treated medically. The rates of major bleeding (including intracranial hemorrhage) at 30 days were 2.1% in the enoxaparin group and 1.4% in the UFH group (p<0.001). The 30 day rate of the composite endpoint of death, myocardial nonfatal re-infarction or nonfatal intracranial hemorrhage (a measure of net clinical benefit) was significantly lower in the enoxaparin group as compared to the unfractionated heparin group (10.1% vs. 12.2%, p<0.001). "The FDA approval is a significant milestone in the evaluation of treatment options of patients with STEMI," said Elliott Antman, M.D., Senior Investigator TIMI Study Groups, Director, Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital, Professor of Medicine, Harvard Medical School, and lead investigator of the ExTRACT-TIMI 25 study. "With its new indication, enoxaparin is now applicable across the full spectrum of acute coronary syndrome conditions including unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) and ST-segment elevation myocardial infarction (STEMI)." Sanofi-aventis has also submitted a dossier for the STEMI indication in European countries including France, Germany, UK, Italy and Spain. About Coronary Artery Disease and Acute Coronary Syndrome Coronary artery disease (CAD) is the most common type of heart disease globally, and is a serious health problem worldwide. CAD causes approximately 17 million deaths per year: the equivalent of one out of every three deaths worldwide. According to the American Heart Association, more than 13 million Americans have a history of CAD and 7.5 million have experienced an acute heart attack. Acute coronary syndrome (ACS) is an umbrella term used to describe a group of clinical diagnoses caused by narrowing of the coronary arteries and cover any group of clinical symptoms compatible with acute myocardial ischemia, caused by an imbalance between myocardial oxygen supply and demand that results from CAD. Immediate treatment is required for all ACS. The treatment approach is multifaceted and aims to try and protect the affected heart muscle from further damage, reinstate blood flow through the artery and reduce the heart's demand for oxygen. In the emergency room, the primary goals are to rapidly identify patients with MI (STEMI), exclude alternative causes of chest pain, and stratify patients into low- and high-risk groups and provide appropriate therapy to minimize further damage or ischemia to cardiac muscle. Restoration of blood to the heart (reperfusion) can be achieved either via the use of certain drugs (fibrinolytics), used to break down blood clots, or mechanically by surgery (i.e. Percutaneous Coronary Intervention (PCI)]. Pharmacological options for the treatment ACS include the use of antiplatelet agents to help prevent platelets from sticking together and forming clots, and anticoagulants to prevent blood clotting. Anticoagulants prevent clots from growing and new ones from forming, but they do not dissolve clots. About Lovenox(R) Lovenox(R) is a unique chemical entity in a class of antithrombotic agents known as low-molecular weight heparin (LMWH). The number one selling low-molecular weight heparin in the world, Lovenox(R) is obtained by alkaline degradation of heparin benzyl ester and is about one-third the molecular size of unfractionated heparin. Lovenox(R) is the most widely studied LMWH, with 15 years of use in the treatment of 130 million patients in 96 countries. Lovenox(R) is approved in the United States for the prophylaxis of ischemic complications of unstable angina and non-Q-wave (non-ST-segment elevation) myocardial infarction when concurrently administered with aspirin and for the prophylaxis of deep vein thrombosis (DVT) which may lead to pulmonary embolism (PE); in patients undergoing abdominal surgery who are at risk for thromboembolic complications; in patients undergoing hip replacement surgery (during and following hospitalization), in patients undergoing knee replacement surgery; and in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness; as well as for the inpatient treatment of acute DVT, with or without PE, when administered in conjunction with warfarin sodium and for the outpatient treatment of acute DVT without PE, when administered in conjunction with warfarin sodium. About Deep Vein Thrombosis and Pulmonary Embolism Deep vein thrombosis (DVT) entails the formation of blood clots within deep veins of the body, most commonly occurring in the lower extremity. DVT occurs in up to two million individuals in the United States each year. Pulmonary embolism (PE), a serious complication of DVT, at times fatal, is responsible for the death of approximately 300,000 people each year in the United States - more than breast cancer and AIDS combined. The main problem underneath DVT involves a blockage of blood flow within the deep veins involved, owing to the formation of a blood clot within. Symptoms of acute leg pain and swelling may occur, as consequence of the blockade to blood flow. A PE occurs when part of the blood clot dislodges from its nest in the deep veins, and travels up stream by way of the blood flow, eventually reaching the lung, where it remains trapped. There are many symptoms associated with PE, but the most common ones include shortness of breath, lateral chest pain worsened by deep breath in. There are well known risk factors to DVT, including prolonged immobility, major surgery, chronic medical ailments, cancer, age above 40 years, trauma, oral contraceptives, pregnancy and the post-partum. The management of DVT includes prophylaxis, under certain risk conditions, and acute treatment in patients with a known DVT. The management of DVT involves several treatments including early mobilization, anti-embolism stockings or mechanical, leg-compression devices to enhance blood flow, and anticoagulants and/or blood-thinning drugs. It is important to consult your healthcare professional about the signs and symptoms associated with DVT. About sanofi-aventis Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organisation, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). Forward Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements. 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