Novo Nordisk has received the European Commission's marketing authorization for Victoza for the treatment of type-2 diabetes in adults. The authorization covers all 27 European Union member states.
Victoza is the brand name approved in Europe for liraglutide, the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type-2 diabetes.
On 23 May 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. A New Drug Application was also submitted for approval in Japan on 14 July 2008. In both the US and Japan, a regulatory decision is pending.
The marketing authorization covers combination treatment with metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea. There is also another combination treatment with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.
In clinical studies involving more than 6,500 people with type 2 diabetes, Victoza has shown to have a significant blood glucose-lowering effect leading to weight loss, while having a low risk of hypo-glycaemia. "With this background, we are convinced that the drug is a valuable new treatment option for patients," stated Mads Krogsgaard Thomsen, executive vice president and chief science officer, Novo Nordisk.
Novo Nordisk will launch Victoza in the UK, Germany and Denmark and other European markets beginning now till 2010 in a phased manner.