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Novo Nordisk receives positive opinion on Victoza®
(liraglutide) from the European regulatory authorities

Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMEA) adopted a positive opinion, recommending marketing authorisation, for Victoza® for 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 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.

Novo Nordisk expects to receive final marketing authorisation from the European Commission within approximately two months. Subject to the Commission's approval, Novo Nordisk expects to launch Victoza® in a number of European markets during this summer.

"We are very pleased with the positive opinion from the CHMP, which gives us confidence that Victoza® will soon become available to many people with type 2 diabetes in Europe," says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "In clinical studies involving more than 6,500 patients, 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® will offer people with type 2 diabetes a valuable new treatment option."
About Victoza®

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.



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