Novo Nordisk files for regulatory approval of liraglutide in both the US and Europe

Novo Nordisk has filed a New Drug Application (NDA) in the US and a marketing authorisation application in Europe for liraglutide, a once-daily human GLP-1 analogue, for the treatment of people with type 2 diabetes.

Liraglutide works by stimulating the release of insulin only when glucose levels become too high and by inhibiting appetite. The company claims that in contrast to most other antidiabetic treatments, liraglutide also leads to weight loss instead of weight increase.

Both the US and the European applications contain documentation from an extensive clinical development programme that included around 6,500 people of which approximately 4,200 received liraglutide. The programme was designed to obtain the indication for use of liraglutide to treat type 2 diabetes as an adjunct to diet and exercise, both as monotherapy and in combination with commonly used antidiabetic medications.

The majority of people were included in the phase 3 trials constituting the Liraglutide Effect and Action in Diabetes) programme (LEAD). The programme has compared liraglutide with three widely used classes of antidiabetic drugs - sulfonylurea, glitazone or basal insulin - and the programme confirmed a statistically significant benefit of liraglutide on the primary endpoint, lowering of blood glucose (HbA1c), as well as on the secondary endpoint, weight loss.

Novo Nordisk still expects to file for marketing approval of liraglutide in Japan in the third quarter of 2008.