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  药店国别: 美国药房
产地国家: 美国
所属类别: 心血管系统药物->抗血栓药物
处方药:处方药
包装规格: 5毫克/片 60片/盒
计价单位:
   
生产厂家中文参考译名:
百时美施贵宝
生产厂家英文名:
BRISTOL MYERS SQUIBB
该药品相关信息网址1:
http://www.eliquis.eu/landingpage.aspx
原产地英文商品名:
ELIQUIS 5mg/tab 60tabs/box
原产地英文药品名:
APIXABAN
中文参考商品译名:
ELIQUIS 5毫克/片 60片/盒
中文参考药品译名:
阿哌沙班
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Anticoagulant
英文适应病症2:
Stroke prevention
英文适应病症3:
Thromboprophylaxis
临床试验期:
完成
中文适应病症参考翻译1:
抗凝药
中文适应病症参考翻译2:
预防中风
中文适应病症参考翻译3:
血栓预防
药品信息:

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 详细处方信息以本药内容附件PDF文件(201232218492216.PDF,201232218491619.PDF)的“原文Priscribing Information”为准
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部分中文Eliquis处方资料(仅供参考)

辉瑞与百时美新型抗凝剂Eliquis获欧盟批准
    制药商辉瑞公司(PFE)周五表示,欧盟监管机构已批准其与百时美施贵宝(BMY)合作开发的抗凝剂Eliquis,后者是一款用于防止接受臀部或膝部置换手术的患者血液凝结的药物。
  这一批准意味着该药将能够在欧盟27个成员国内销售。辉瑞与百时美将分享销售利润。
  Eliquis一直被作为一款潜在的畅销药而受到吹捧,因为其能够防止血凝,而且没有象warfarin等旧药物那样的出血副作用。不过,辉瑞与百时美去年仍因为出血过多而被迫暂停了一项涉及1万名患者的试验。

Eliquis(阿哌沙班)比华法林更有优势的抗凝药
    Eliquis(apixaban,阿哌沙班)用于预防中风。针对该药的临床试验取得最佳结果:Eliquis将安全性和有效性完美地结合在一起。
    Eliquis(apixaban,阿哌沙班)与现行的标准治疗药物华法林(warfarin)相比,该药令患者发生严重出血的危险性降低31%。引发出血是血液稀释剂令人担忧的一个副作用。此外,使用Eliquis的患者发生死亡的危险性可降低11%,这是华法林替代产品首次在研究中显示可拯救患者生命。
    目前在治疗中风的抗凝血的药物中,主要有华法林、Pradaxa、Eliquis(apixaban,阿哌沙班)、Xarelto(等待审批)等药。
    心律不齐(或心房颤动)是一个很大的治疗市场。分析师表示,其他患者群(如接受髋关节和膝关节手术的病人)每年可再为这些药物带来30亿~60亿美元的销售额。
    在一项名为ARISTOTLE的研究中,使用Eliquis的患者发生中风的危险性要比华法林低21%。为了配合这次ESC会议,对参与ARISTOTLE研究的每1000名使用Eliquis的患者来说,该药可防止1/6的人发生中风,防止1/15的人发生严重出血,防止1/8的人死亡。辉瑞和百时美施贵宝为这项研究提供了资金,研究对18200名病人进行了跟踪。
    首席研究员、杜克大学临床研究所的ChristoPH erGranger在这次会议上称,患者能从该药中得到更好的疗效。如果继续使用华法林,唯一原因是该药的成本费用较低。
    在Eliquis研究取得良好结果的同时,勃林格殷格翰开发的Pradaxa将遭受损失。与Eliquis或Pradaxa相比,拜耳的药物Xarelto进行研究时,招募的研究对象都是风险更高的患者。由于Xarelto每天使用一次,因此能保持住市场份额。
    华法林也是每日使用一次的药物,而Eliquis和Pradaxa必须每天服用两次。
    分析师进一步表示,百时美施贵宝和辉瑞是心血管治疗药物市场上两个最好的营销者,如果将这一点与Eliquis的研究结果结合在一起,自然会得出谁将成为赢家。

备受瞩目的新药Eliquis在欧洲药品监管机构获批
    辉瑞日前表示,欧洲药品监管机构已批准其备受瞩目的血管稀释剂Eliquis(阿哌沙班),该药用于接受过臀部或膝部置换手术患者的血栓预防。
  该药由辉瑞与百时美施贵宝联合开发,两公司将分享利润,这一批准将意味着该药可以在欧盟的27个成员国使用。
临床研究结果表明,接受2次/天Eliquis治疗的效果要优于接受目前典型注射剂治疗的效果。
  Eliquis能预防血栓,但出血的不良反应低于老药华法林,因而被认为是一只具有“重磅炸弹”潜力的药物。然而,辉瑞去年被迫停止一项有10000例心脏病史患者参与的临床试验,试验停止的原因是由于使用本品后,出现了许多意外的出血副作用。
  Eliquis在美国还未上市,辉瑞和百时美施贵宝计划今年晚些时候向FDA提交上市申请,他们正争取将该有用于预防中风,主要用于有心脏病的患者。

ELIQUIS? (apixaban) Approved in Europe for Preventing Venous Thromboembolism after Elective Hip or Knee Replacement
The European Commission has approved ELIQUIS? in the 27 countries of the European Union (EU) for the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. This decision marks the first approval for ELIQUIS?, a new oral direct Factor Xa inhibitor being developed by the alliance of Bristol-Myers Squibb Company and Pfizer Inc.
"Major orthopedic surgery, such as total knee replacement or total hip replacement, puts patients at a very high risk of developing VTE or pulmonary embolism. The absolute risk of deep vein thrombosis for these patients ranges from 40 to 60 percent when these patients do not receive preventive care," said Michael Rud Lassen, M.D., Glostrup Hospital in Copenhagen, Denmark, and lead investigator for the Phase 3 orthopedic trials for ELIQUIS. "The approval of ELIQUIS gives European orthopedic surgeons a new option in VTE prevention that is more effective than the current standard of care, enoxaparin 40 mg once daily, and importantly, without increasing bleeding."

The approval of ELIQUIS is based on the ADVANCE-2 and ADVANCE-3 clinical trials, part of the EXPANSE clinical trial program. In these trials, ELIQUIS given orally twice daily demonstrated superior efficacy versus enoxaparin 40 mg given once daily by injection in the prevention of VTE in total knee and total hip replacement, and did not increase the risk of bleeding versus enoxaparin. These trials randomized over 8,000 patients and assessed the safety and efficacy of ELIQUIS compared to enoxaparin. The primary efficacy endpoint of ADVANCE-2 and ADVANCE-3, which studied patients undergoing elective total knee or hip replacement, respectively, was defined as the composite of asymptomatic and symptomatic deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE), and death from any cause during study treatment. The principal safety measure in the trials was the composite of major and clinically relevant non-major bleeding.

ELIQUIS is the only oral anticoagulant with a 12- to 24-hour post surgery initiation window, which may help physicians to observe and stabilize post-surgical patients before beginning treatment. ELIQUIS is dosed 2.5 mg twice daily, requires no routine platelet or liver monitoring, and requires no dose adjustment in indicated patients. In patients undergoing hip replacement surgery, the recommended duration of treatment is 32 to 38 days. In patients undergoing knee replacement surgery, the recommended duration of treatment is 10 to 14 days.

"As the first ELIQUIS approval worldwide, today marks an important milestone for the Bristol-Myers Squibb/Pfizer Alliance," said Beatrice Cazala, senior vice president, Commercial Operations, and president, Global Commercialization, Europe and Emerging Markets, Bristol-Myers Squibb. "We are confident that our shared resources and leadership in the treatment of cardiovascular disease will help make the European launch a success and continue to bring value to the development of ELIQUIS."

"The approval of ELIQUIS provides a new oral option for patients in the EU undergoing elective hip or knee replacement surgery, where the risk of bleeding is a significant concern," said Olivier Brandicourt, president and general manager, Primary Care, Pfizer Inc. "We are excited to bring this new agent to market in Europe and provide orthopedic surgeons with an option that will help them to prevent VTE in patients undergoing elective total knee or total hip replacement surgery."

About Venous Thromboembolism
VTE encompasses two serious conditions: DVT, a blood clot in a vein, usually in the leg that partially or totally blocks the flow of blood; and PE, a blood clot blocking one or more vessels in the lungs. DVT causes multiple symptoms including pain, swelling and redness and, more importantly, can progress to PE, which carries the risk of sudden death.

About the ELIQUIS? Clinical Trial Program
ELIQUIS? is being investigated within the EXPANSE Clinical Trials Program, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind Phase 3 trials, including the ADVANCE trials.

In addition to prevention of VTE in orthopedic surgery, ELIQUIS is being investigated in Phase 3 trials for the treatment of VTE, the prevention of VTE in hospitalized acutely ill medical patients and the prevention of stroke and other thromboembolic events in patients with atrial fibrillation.

About the Bristol-Myers Squibb/Pfizer Collaboration
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize ELIQUIS, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer's global scale and expertise in this field.

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 详细处方信息以本药内容附件PDF文件(201232218492216.PDF,201232218491619.PDF)的“原文Priscribing Information”为准
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更新日期: 2019-1-16
附件:


201232218492216.PDF    

201232218491619.PDF    

 
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