部分中文Axanum处方资料（仅供参考）

Axanum(阿司匹林/埃索美拉唑镁)欧洲递交上市申请

AstraZeneca公司表示已向欧洲递交了Axanum的上市申请，申请用于需要持续使用低剂量阿司匹林的患者以预防心脑血管事件的发生。Axanum为一种低剂量的阿司匹林与埃索美拉唑镁(esomeprazole magnesium)组成的复方制剂。不久前美国FDA向该复方制剂的上市申请发出了完全回复信。
                     
低剂量的阿司匹林是预防发生心脑血管事件的主要药物之一，但是可引起胃十二指肠溃疡的风险，而使患者放弃使用阿司匹林。30%有上消化道问题的使用者停止使用低剂量的阿司匹林。支持该项申请的资料来自于两项名为Asterix与Oberon的3期试验，表明增加使用埃索美拉唑镁可降低上消化道溃疡的发生率。
AXANUM欧洲上市申请获批
阿斯利康公司当日宣称，AXANUM的欧洲上市申请已经获得批准。
AXANUM为81mg阿司匹林与20mg埃索美拉唑镁 (esomeprazole magnesium)组成的复方制剂，用于预防心脏病发作，中风等心脑血管事件的发生。低剂量的阿司匹林是预防心脑血管事件发生的主要药物之一，但可引起胃十二指肠溃疡。研究人员对埃索美拉唑镁进行了一项双盲、随机、前瞻性研究后发现，2,426名胃溃疡患者经26周治疗后，胃溃疡发生率下降了85个百分点。由此可见，AXANUM复方制剂可降低使用低剂量阿司匹林发生胃十二指肠溃疡的风险。

阿斯利康新药在欧审批乐观
2011年8月2日,阿斯利康公司宣布其新药AXANUM(81mg低剂量阿司匹林+20mg埃索美拉唑)在欧盟23国及挪威的审批进程中获得了积极同意。
AXANUM的适应症为预防高风险心血管病人的心血管事件(例如心脏病突发或中风),这类病人需要低剂量阿司匹林的持续治疗,有部分病人还伴有胃溃疡风险。低剂量的阿司匹林是高风险心血管病人的推荐主要支持疗法,但约有1/3的病人因此而会增加胃溃疡和胃肠道出血的风险,因此,停止低剂量阿司匹林治疗的最常见原因通常都是上消化道问题。然而,中断低剂量阿司匹林治疗的后果可能会非常严重,因为在停用低剂量阿司匹林后,最短可能在8~10天内发生心脏病突发或中风。
而AXANUM则是唯一一种对低剂量阿司匹林引发的胃溃疡具有内在预防机制的新药,这意味着AXANUM可以让心血管病人安全持续地使用低剂量阿司匹林治疗。AXANUM的用量为每日一片,其有效成分之一的埃索美拉唑也是阿斯利康的重要产品耐信(Nexium,一种质子泵抑制剂)的活性成分。耐信用于降低低剂量阿司匹林使用者的消化道溃疡风险,也是唯一一种获批用于降低消化道出血患者的再出血风险的质子泵抑制剂。耐信在去年全年的销售额接近50亿美元,是阿斯利康的第二热销产品(第一是可定Crestor),今年上半年的销售额接近23亿美元。
阿斯利康于2009年4月30日向欧盟提交AXANUM的上市申请。欧盟对AXANUM审批的积极同意决定是基于分散式程序(DCP),其中德国是作为参考成员国。随后还将在欧盟各成员国获批以及进行地方性定价/报销的商谈。
目前美国FDA尚未批准AXANUM在美上市。
                  
Positive agreement received for approval of AXANUM (low-dose ASA/esomeprazole) in Europe
AstraZeneca today announced that AXANUM, a fixed dose combination of 81 mg low-dose ASA (acetylsalicylic acid) and 20 mg esomeprazole, has received positive agreement for approval in 23 European Union member countries and in Norway.
AXANUM is indicated for prevention of cardiovascular (CV) events such as heart attack or stroke, in high-risk CV patients in need of daily low-dose ASA treatment and who are at risk of gastric ulcers.
Low-dose ASA (commonly known as aspirin) is recommended mainstay therapy for patients with high-risk for cardiovascular events. About one third of these patients are also at increased risk of stomach ulcer.
Low-dose ASA further increases the risk for gastric ulcers and gastrointestinal bleeding. In fact, the most common reason for stopping low-dose ASA treatment is upper gastrointestinal problems.
The consequences of interrupting low-dose ASA treatment can be severe, increasing the risk of a heart attack or stroke as early as eight to 10 days later.
AXANUM is the only medicine that ensures every single pill of low-dose ASA comes with built-in protection against gastric ulcers. That means AXANUM has the potential to provide continuous CV protection in this patient population.
The EU decision took place under the decentralised procedure (DCP), with Germany acting as reference member state. This process is now followed by national approvals and local pricing and reimbursement discussions.
Tony Zook, Executive Vice President of AstraZeneca’s Global Commercial Organisation said: “AstraZeneca has had some significant regulatory approvals this year, and we’re pleased
with this positive agreement for AXANUM in Europe. We will now work with relevant health authorities to secure reimbursement decisions and get onto formularies to bring this medicine to patients as soon as possible.”
About AXANUM
AXANUM once-daily pill is a combination of low-dose ASA 81mg and esomeprazole 20mg. Esomeprazole, which is the active ingredient in the proton pump inhibitor (PPI) Nexium, is
approved for the risk reduction of peptic ulcer development in low-dose ASA patients and is the only PPI approved for the risk reduction of re-bleeding in peptic ulcer bleed patients.
AstraZeneca submitted a Marketing Authorisation Application in the EU via the Decentralised Procedure for AXANUM on 30 April 2009. The EU Concerned Member States include: Austria; Belgium, Denmark, Luxemburg, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Greece, Finland, France, Italy, Lithuania, Latvia, Malta, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia and Norway. The Member States will now work to pursue pricing/reimbursement and national approvals.
About the OBERON Study
The data from the OBERON trial, a double-blind, randomised, prospective analysis of 2426 patients, revealed that esomeprazole 20mg reduced the cumulative proportion of patients with peptic ulcers after 26 weeks of treatment by 85%.
About the ASTERIX Study
Data from the ASTERIX study, a double-blind, randomized, placebo-controlled of 992 patients, reported that Nexium 20 mg once daily was significantly more effective than placebo in preventing gastric and/or duodenal ulcers and associated upper GI problems in this patient group.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease.
AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
附件:
201242300324524.PDF

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产地国家: 欧洲共同体国家
原产地英文商品名:
AXANUM HARTKAPSELN (81mg/20mg)/cap 90caps/box
原产地英文药品名:
ACETYLSALICYLIC ACID/ESOMEPRAZOLE
中文参考商品译名:
AXANUM硬胶囊剂 (81毫克/20毫克)/胶囊 90胶囊/盒
中文参考药品译名:
阿斯匹林/埃索美拉唑
生产厂家中文参考译名:
阿斯利康
生产厂家英文名:
AstraZeneca GmbH
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产地国家: 欧洲共同体国家
原产地英文商品名:
AXANUM HARTKAPSELN (81mg/20mg)/cap 30caps/box
原产地英文药品名:
ACETYLSALICYLIC ACID/ESOMEPRAZOLE
中文参考商品译名:
AXANUM硬胶囊剂 (81毫克/20毫克)/胶囊 30胶囊/盒
中文参考药品译名:
阿斯匹林/埃索美拉唑
生产厂家中文参考译名:
阿斯利康
生产厂家英文名:
AstraZeneca GmbH