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news.Denmark-based healthcare company Novo Nordisk has announced that the Committee for Medicinal Products for Human Use under the European Medicines Agency has adopted a positive opinion, recommending marketing authorization, for Victoza for treatment of type 2 diabetes.
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Victoza is the brand name for liraglutide, the first once-daily human glucagon-like peptide-1 (GLP-1) analog developed for the treatment of type 2 diabetes, the company said.
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, and combination treatment with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycemic control despite dual therapy.
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 a number of European markets during the summer of 2009.
Mads Thomsen, executive vice president and chief science officer of Novo Nordisk, said: “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.
“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 hypoglycemia. On this background, we are convinced that Victoza will offer people with type 2 diabetes a valuable new treatment option.”