BAGSVAERD, DENMARK--(Marketwire - July 03, 2009) - Novo Nordisk’s Victoza® (liraglutide) receives marketing authorisation in Europe
Novo Nordisk announced today that the European Commission has granted marketing authorisation for Victoza® for the treatment of type 2 diabetes in adults. The authorisation covers all 27 European Union member states.
Victoza® is the brand name approved in Europe for liraglutide, the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. The marketing authorisation covers:
* combination treatment with metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea, and * combination treatment with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.
“This is an important milestone for Novo Nordisk and for the treatment of type 2 diabetes,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “In clinical studies involving more than 6,500 people with type 2 diabetes, Victoza® has been shown to have a significant blood glucose-lowering effect and lead to weight loss, while having a low risk of hypoglycaemia. On this background, we are convinced that Victoza® is a valuable new treatment option for people with type 2 diabetes.”
Novo Nordisk will launch Victoza® in the UK, Germany and Denmark during the summer and in other European markets during the second half of 2009 and throughout 2010.
The marketing approval in Europe does not change Novo Nordisk’s expectations for the company’s financial results for 2009. Novo Nordisk will provide an update on the expectations for the company’s financial results for 2009 on 6 August 2009 in connection with the release of the financial results for the first six months of 2009.
About Victoza®
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 only when blood sugar levels are high. Weight loss with Victoza® is attributed to the fact that it slows gastric emptying and leads to increased satiety after meals. Victoza® is naturally broken down in the body and does not require renal excretion.
Throughout the clinical development programme, which involved more than 6,500 patients, Victoza® has demonstrated a favourable benefit:risk profile and has been compared to widely used diabetes treatments such as sulphonylureas (SUs) , thiazolidinediones (TZDs), insulin glargine and exenatide.
On 23 May 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration in the US as well as a marketing authorisation application to the European Medicines Agency in Europe, for the approval of Victoza® for the treatment of people with type 2 diabetes. A New Drug Application was also submitted for approval in Japan on 14 July 2008.
In both the US and Japan, a regulatory decision is 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 27,900 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.
Contacts for further information Media: Investors: Mike Rulis Mads Veggerby Lausten Tel: (+45) 4442 3573 Tel: (+45) 4443 7919 mike@novonordisk.com mlau@novonordisk.com Kasper Roseeuw Poulsen Tel: (+45) 4442 4471 krop@novonordisk.com In North America: In North America: An Phan Hans Rommer Tel: (+1) 609 558 0420 Tel: (+1) 609 919 7937 anph@novonordisk.com hrmm@novonordisk.com
Company Announcement no 40 / 2009
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