Regulatory Approval
(Thomson Reuters ONE) - Novo Nordisk receives approval for Victoza® in JapanNovo Nordisk today announced that the Japanese Ministry of Health, Labour andWelfare 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 2diabetes. 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 thetreatment of type 2 diabetes and an important milestone for Novo Nordisk." saysMads Krogsgaard Thomsen, executive vice president and chief science officer ofNovo Nordisk. "We are excited to pioneer the GLP-1 market in Japan, where we areconvinced Victoza® will prove to be a valuable treatment option for people withtype 2 diabetes. The clinical studies conducted in Japan showed Victoza® toprovide superior glucose control with a low risk of hypoglycaemia."Novo Nordisk expects to launch Victoza® in Japan in the first half of 2010 uponcompletion of price negotiations.About Victoza®Once-daily Victoza® is the first human Glucagon-Like Peptide-1 (GLP-1) analoguedeveloped for the treatment of type 2 diabetes. Victoza® works by stimulatingthe release of insulin from the pancreatic beta cells only when blood sugarlevels are high. Weight loss with Victoza® is attributed to the fact that itleads 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 anddoes not depend upon renal excretion.In Europe, Novo Nordisk received marketing authorisation for Victoza® on 30 Juneand Victoza® has subsequently been launched in several countries. A New DrugApplication was submitted for regulatory approval in the US in May 2008 and inChina in August 2009, respectively, and regulatory decisions are pending.Novo Nordisk is a healthcare company and a world leader in diabetes care. Inaddition, Novo Nordisk has a leading position within areas such as haemostasismanagement, growth hormone therapy and hormone replacement therapy. Novo Nordiskmanufactures and markets pharmaceutical products and services that make asignificant difference to patients, the medical profession and society. Withheadquarters in Denmark, Novo Nordisk employs more than 29,000 employees in 81countries, and markets its products in 179 countries. Novo Nordisk's B sharesare listed on the stock exchanges in Copenhagen and London. Its ADRs are listedon the New York Stock Exchange under the symbol 'NVO'. For more information,visit novonordisk.com.Further information: Media: Investors: Mike Rulis Klaus B? Davidsen Tel: (+45) 4442 3573 Tel: (+45) 4442 3176 mike(at)novonordisk.com klda(at)novonordisk.com
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Datum: 20.01.2010 - 02:00 Uhr
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