Novo Nordisk has submitted its new antidiabetic liraglutide, a compound that is being seen as vital to the Danish firm’s future prospects, to regulators on both sides of the Atlantic.

The firm has submitted a New Drug Application to the US Food and Drug Administration, as well as a marketing authorisation application to the European Medicines Agency, for the approval of liraglutide, a once-daily human glucagon-like peptide-1 (GLP-1) analogue, for the treatment of people with type 2 diabetes. The applications are based on data from 6,500 patients (of which 4,200 received liraglutide) and the trials tested the drug as an adjunct to diet and exercise, both as monotherapy and in combination with other antidiabetics, ie sulfonylureas, glitazones or basal insulin.

The studies showed a “statistically significant benefit” in lowering blood glucose levels, and liraglutide was also associated with weight loss and Novo added that expects to file for marketing approval of the drug in Japan in the third quarter of 2008.

If approved, liraglutide will compete with the once-weekly formulation of Eli Lilly and Amylin's Byetta (exenatide). Analysts have estimated peak sales in the region of 8 billion Danish kroner (around $1.7 billion) in 2014 and will drive Novo’s sales over the next five years.

The company’s diabetes division rose 10% to 7.84 billion kroner in the first quarter of 2008, with the firm's stable of modern insulin contributing 3.82 billion kroner of the total, an increase of 25% on the year before.