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继日本中央社会保险医疗委员会批准了Victoza®（利拉鲁肽）的定价之后，诺和诺德制药公司计划将尽快在当地市场推出这种产品。诺和诺德表示，Victoza®是首个在日本获准上市的GLP-1类药物，既可以单独用药，也可以作为辅助药物与磺脲类降糖药(SU)联用。
利拉鲁肽即将进入日本市场
继日本中央社会保险医疗委员会批准了Victoza®（利拉鲁肽）的定价之后，诺和诺德制药公司计划将尽快在当地市场推出这种产品。诺和诺德表示，Victoza®是首个在日本获准上市的GLP-1类药物，它在治疗过程中既可以单独用药，也可以作为辅助药物与磺脲类降糖药(SU)联用。
迄今为止，Victoza®已在美国、加拿大、英国、德国和丹麦等国家有售。2009年8月份，该药也在中国递交了上市申请，目前尚待药监部门的批准。
Victoza® to be launched in Japan in June (2 June 2010)
Novo Nordisk today announced that it has received approval of the price of Victoza®, a once-daily human GLP-1 analogue for the treatment of type 2 diabetes, from Japan’s Central Social Insurance Medical Council (Chuikyo), the advisory committee to the Minister of Health, Labour and Welfare.
The price approval allows Novo Nordisk to commercially launch in Japan shortly after Victoza® is officially posted on Japan’s National Health Insurance price list 11 June.
Victoza® is the first GLP-1 to achieve regulatory approval and commercial availability in Japan. It is indicated for the treatment of type 2 diabetes when used as monotherapy or as an add-on to sulphonylurea (SU).
Victoza® was approved by the Minister of Health, Labour and Welfare on 20 January 2010 based on a clinical development programme specifically tailored to the needs of people with type 2 diabetes in Japan.
About Victoza®
Victoza® is the only human GLP-1 analogue; it has 97% homology to natural GLP-1. Like natural GLP-1, Victoza® (liraglutide) works by stimulating the beta cells to release insulin only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza® is associated with a low rate of hypoglycaemia. The mechanism of blood sugar lowering also involves a delay in gastric emptying.
Victoza® was approved by the US Food and Drug Administration (FDA) on 25 January 2010 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.
Victoza® was approved by the European Commission in all 27 European Union member states on 30 June 2009. As of May 2010, approval has also been granted by the regulatory authorities in Japan, Norway, Mexico, Iceland, Switzerland, Lebanon, India, Macedonia, Brazil, Canada, Croatia, Argentina, Qatar and Russia. Victoza® has already been commercially launched in the US and Canada as well as the UK, Germany and Denmark and a number of other European countries; it will be available in other markets throughout 2010. A New Drug Application was also submitted for approval in China in August 2009. A regulatory decision is pending.
For more information on Victoza®, visit novonordisk.com – Media – Victoza® press room.
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 87 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk.com.
编辑: xiaoyan 作者:丁香园通讯员
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