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CHMP Recommends Approval of Novo Nordisk’s Victoza(R) (Liraglutide) for Type 2 Diabetes

Novo Nordisk announces that the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMEA) adopted a positive opinion, recommending marketing authorization, for Victoza® for the treatment of Type 2 diabetes.

Victoza® is the brand name for liraglutide, the first once-daily human Glucagon-like peptide-1 (GLP-1) analogue developed for the treatment of Type 2 diabetes. The positive opinion for Victoza® covers: combination treatment with metformin or a sulphonylurea in patients with insufficient glycemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea, (i.e. second-line use after one oral agent).

Also, in combination treatment with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycemic control despite dual therapy (i.e. third-line use after two oral agents).

Novo Nordisk expects to receive final marketing authorization from the European Commission within approximately two months. Subject to the commission’s approval, Novo Nordisk expects to launch Victoza® in selected European markets, including the UK, in Q3.

“With the recent announcement of a positive opinion from the CHMP, we are optimistic that Victoza® will soon be approved for patients with Type 2 diabetes, providing a valuable new therapy and improving treatment options for patients in the UK,” said Viggo Birch, Managing Director, Novo Nordisk UK and Ireland.

“We are very much looking forward to the availability of Victoza® for our patients in the UK,” said Professor Steve Gough, Selly Oak Hospital, Birmingham. “There is no doubt that there is a great unmet need for a treatment with Victoza’s® benefits and physicians in the UK are very encouraged by data from the comprehensive and extensive LEAD (Liraglutide Effect and Action in Diabetes) clinical study program.”

Victoza® is the first once-daily human Glucagon-like peptide-1 (GLP-1) analogue developed for the treatment of Type 2 diabetes. Victoza® works both by stimulating the release of insulin when glucose levels become too high, and by reducing appetite. On May 23, 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration in the US, as well as a marketing authorization application to the European Medicines Agency in Europe, for the approval of Victoza® for the treatment of people with Type 2 diabetes. Decisions from each are expected to be made this year. A New Drug Application was also submitted for approval in Japan on July 14, 2008, with a decision expected in 2010.

Novo Nordisk

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