Novo Nordisk receives approval for Victoza in Japan
Novo Nordisk receives approval for Victoza® in Japan
Novo Nordisk today announced that the Japanese Ministry of Health, Labour and Welfare has approved Victoza® for the treatment of type 2 diabetes.
Victoza® is the brand name for liraglutide, the first Glucagon-Like Peptide-1 (GLP-1) analogue approved in Japan, developed for the treatment of type 2 diabetes. Victoza® is indicated as monotherapy or as an add-on to sulphonylurea (SU) in people with type 2 diabetes.
"The Japanese approval of Victoza® represents a major advancement in the treatment of type 2 diabetes and an important milestone for Novo Nordisk." says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "We are excited to pioneer the GLP-1 market in Japan, where we are convinced Victoza® will prove to be a valuable treatment option for people with type 2 diabetes. The clinical studies conducted in Japan showed Victoza® to provide superior glucose control with a low risk of hypoglycaemia."
Novo Nordisk expects to launch Victoza® in Japan in the first half of 2010 upon completion of price negotiations.
Once-daily Victoza® is the first human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. Victoza® works by stimulating the release of insulin from the pancreatic beta cells only when blood sugar levels are high. Weight loss with Victoza® is attributed to the fact that it leads to increased satiety after meals in part by slowing gastric emptying and, in part, by other mechanisms. Victoza® is broken down naturally in the body and does not depend upon renal excretion.
In Europe, Novo Nordisk received marketing authorisation for Victoza® on 30 June and Victoza® has subsequently been launched in several countries. A New Drug Application was submitted for regulatory approval in the US in May 2008 and in China in August 2009, respectively, and regulatory decisions are pending.
Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs more than 29,000 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit novonordisk.com.
Kasper Roseeuw Poulsen
Tel: (+45) 4442 4471