Victoza is a once-daily human GLP-1 analogue for the treatment of type 2 diabetes.
The price approval allows Novo Nordisk to launch in Japan shortly after Victoza is officially posted on Japan’s National Health Insurance price list on June 11.
Novo Nordisk said that 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).
Earlier, 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.
Reportedly, 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.