European regulators have affirmed their September recommendation that the three pandemic influenza A(H1N1) vaccines approved in the European Union should be given in two separate doses at least three weeks apart.

During a meeting in London Oct. 18-22, the European Medicines Agency’s (EMEA) human drugs panel reviewed data indicating that one dose of either Pandemrix or Focetria may provide sufficient protection for adults aged from 18 to 60 years. Despite these findings, the data were “too limited to allow the committee to recommend the general use of a single-dose vaccination schedule” for adults in this age group, the agency said in a statement published Oct. 23.

Still, “consideration may be given” to a one-dose schedule for adults and children older than 10 vaccinated with Pandemrix, and for those older than 9 vaccinated with Focetria, the panel said.

For Celvapan, the panel recommended two doses for all age groups.

At the time of the vaccines’ marketing authorization in September, the committee recommended the two-dose schedule but asked manufacturers to supply data from ongoing clinical trials as soon as they became available. The committee considered this new data at the meeting, resulting in the affirmation of its earlier recommendation.

Also during the meeting, the committee:

—Recommended approval of besilesomab, marketed as Scintimun by CIS bio international, a radiopharmaceutical used in scintigraphic imaging to detect inflammation or infection in peripheral bone in adults with suspected osteomyelitis.

—Recommended changing the indication of tadalafil, marketed as Adcirca from Eli Lilly Nederland B.V., to pulmonary arterial hypertension. The drug was previously authorized as Tadalafil Lilly for the treatment of erectile dysfunction. Lilly is withdrawing that indication and replacing it with the new indication.

—Recommended extending the indication of bivalirudin, marketed as Angiox by The Medicines Company UK Ltd, to include patients with ST-segment myocardial infarction undergoing primary percutaneous coronary intervention. Angiox is currently authorized for treatment of patients with unstable angina/non-ST segment elevation myocardial infarction planned for urgent or early surgical intervention.

—Recommended extending the indication of duloxetine–marketed as Cymbalta by Eli Lilly Nederland B. V., and as Xeristar by Boehringer Ingelheim International GmbH—to include treatment of major depressive disorder. Both products are currently authorized for the treatment of major depressive episodes, diabetic peripheral neuropathic pain in adults, and generalized anxiety disorder.

All EMEA recommendations must be ratified by the European Commission.

Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

欧洲管理者确认，9月份推荐的经欧盟批准的3种大流行性甲型(H1N1)疫苗应分两剂使用，使用间隔为3周。

 

10月18~22日于伦敦举行的会议上，欧洲药品管理局(EMEA)人类药物小组回顾了提示Pandemrix和Focetria单剂用药可为18~60岁成人提供足够保护的资料。尽管有这些发现，但对该年龄段成人来说，现有资料“十分有限，委员会不能给出普遍使用单剂疫苗的建议”，EMEA在10月23日的声明中说。

 

但是，该小组说，“仍可考虑”对>10岁的儿童和成人给予单剂的Pandemrix进行免疫，或对≥9岁的儿童和成人给予单剂的Focetria。

 

而对于Celvapan，该小组建议对所有年龄段的人都分两剂用药。

 

当9月份疫苗开始供应的时候，委员会就建议分两剂给药，但要求药厂尽快提供进行中的临床试验数据。委员会在此次会议上分析了新的数据，结论是再次确认了其先前给出的建议。

 

此次会议上，委员会还：

 

－建议批准商品名为Scintimun(由CIS国际生物公司生产)的一种放射性药物(besilesomab)，该药物用于闪烁造影术，以检查怀疑为骨髓炎成年患者骨骼的炎症或感染。

 

－建议变更商品名为Adcirca(由礼来公司生产)的他达那非的适应证，来治疗肺动脉高压症。此前该药用于治疗勃起功能障碍。礼来申请撤销该适应证，改为治疗肺动脉高压症。

 

－建议扩大商品名为Angiox(由The Medicines英国公司生产)的比伐卢定的适应证，用于因ST段抬高心肌梗死而进行经皮冠状动脉介入术的患者。目前，Angiox被批准用于拟行急性或早期介入手术的不稳定心绞痛或非ST段抬高心肌梗死患者。

 

－建议扩大商品名为Cymbalta(由礼来公司生产)和商品名为Xeristar(由勃林格殷格翰生产)的度洛西汀的适应证，以治疗重症抑郁症。此前两种药物被批准用于治疗重度抑郁发作、糖尿病外周神经疼痛和广泛性焦虑症。

 

所有EMEA建议必须得到欧盟委员会的正式批准。

 

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