Novo Nordisk receives US approval for Victoza® for the treatment of type 2 diabetes
Novo Nordisk has announced that the US Food and Drug Administration(FDA) has granted marketing authorisation for
Victoza® for the treatment oftype 2 diabetes in adults.
Victoza® is the brand name approved in the US and Europe for liraglutide, the first once-daily human Glucagon-Like
Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. In the US, Victoza® is indicated as an
adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. This provides for Victoza®
to be used in monotherapy, as second-line treatment and in combination with commonly prescribed oral medications
for diabetes.
“The US approval of Victoza® represents a major advancement in the treatment of type 2 diabetes and is an important
milestone for Novo Nordisk that follows the recent approval in Japan and the ongoing successful launch in Europe.”
says Lars Rebien Sørensen, president and CEO. “We are convinced that Victoza® will prove to be a valuable treatment
option for people with type 2diabetes in the US. The ability of Victoza® to substantially improve glucose control with a low
risk of hypoglycaemia creates an opportunity for more patients with type 2 diabetes to achieve their individual treatment
goals.” Novo Nordisk expects to introduce Victoza® in the US market within weeks.
In Europe, Novo Nordisk received marketing authorisation for Victoza® on 30 June and Victoza® has subsequently been
launched in the UK, Germany, Denmark, Norway and Ireland. In Japan, Novo Nordisk received marketing authorisation for
Victoza® on 20 January 2010. A regulatory decision is pending in China where a New Drug Application was submitted in
August 2009.
For further information, please contact:
Katrine Sperling
Tel: (+45) 3079 6718
krsp@novonordisk.com
or visit: www.novonordisk.com
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© 2009