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
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
http://hugin.info/2013/R/1327032/312546.pdf
http://novonordisk.com
Copyright © Hugin AS 2009. All rights reserved.