Novo Nordisk seeks approval of new Type 2 diabetes drug in US, Europe

Novo Nordisk A/S of Denmark, the world's biggest maker of insulin, has filed for regulatory approval of its experimental Type 2 diabetes drug `liraglutide' in the United States and Europe.

Novo Nordisk has submitted a new drug application (NDA) to the Food and Drug Administration (FDA) in the US as well as a marketing authorisation application to the European Medicines Agency (EMEA) in Europe, for liraglutide.

Liraglutide, a once-daily dosage, is an engineered version of the human GLP-1 hormone that stimulates release of insulin when glucose levels become too high and is meant for the treatment of people with Type 2 diabetes, the company said in a release.

Liraglutide works by stimulating the release of insulin only when glucose levels become too high and by inhibiting appetite. 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 company said, adding ''The majority of people were included in the Phase 3 trials constituting the `Liraglutide Effect and Action in Diabetes' programme.

"We are enthusiastic about the prospect of bringing liraglutide to market after completion of the regulatory process," said chief science officer Mads Thomsen.