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.
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.
About Novo Nordisk
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.