Regulatory Approval
January 20 2010 - 1:59AM
UK Regulatory
TIDMNVOB
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.
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 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.
Further information:
Media: Investors:
Mike Rulis Klaus Bülow Davidsen
Tel: (+45) 4442 3573 Tel: (+45) 4442 3176
mike@novonordisk.com klda@novonordisk.com
<mailto:mike@novonordisk.com> <mailto:klda@novonordisk.com>
Kasper Roseeuw Poulsen
Tel: (+45) 4442 4471
krop@novonordisk.com
<mailto: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
<mailto:anph@novonordisk.com> <mailto:hrmm@novonordisk.com>
Company Announcement no 2 / 2010
[HUG#1375094]
Company Announcement no 2 2009: http://hugin.info/2013/R/1375094/337282.pdf
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