Sue Marshall blogs about diabetes for Desang

Victoza approved for US market | February 3, 2010

Novo Nordisk has announced that the US Food and Drug Administration (FDA) has granted marketing authorisation for Victoza® for the treatment of type 2 diabetes in adults.1

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, (although not as first line therapy) and in combination with commonly prescribed oral medications for diabetes.

In Europe, EU Commission granted marketing authorisation for liraglutide on 30 June 2009, for all 27 European Union member states.2 It has been on the market in the UK since 7 July 2009. According to the EU authorisation, liraglutide is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with:

– Metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea, and

– Metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.

“The US approval of liraglutide represents 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 liraglutide will prove to be a valuable treatment option for people with type 2 diabetes in the US.”

Novo Nordisk expects to introduce Victoza in the US market within weeks.



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