Once A Day GLP-1 Liraglutide Coming Soon

Novo Nordisk files for regulatory approval of once-a-day liraglutide in both the US and Europe

Novo Nordisk announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the US as well as a marketing authorization application to the European Medicines Agency (EMEA) in Europe, for the approval of liraglutide, a once-daily human GLP-1 analogue, for the treatment of people with type 2 diabetes.

Both the US and the European applications contain documentation from an extensive clinical development program that included around 6,500 people of which approximately 4,200 received liraglutide. The program 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 LEAD™ (Liraglutide Effect and Action in Diabetes) program. The LEAD™ program has compared liraglutide with three widely used classes of antidiabetic drugs – sulfonylurea, glitazone or basal insulin – and the program 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.

Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk, said: "This is a major achievement for Novo Nordisk and it represents a huge amount of work done by Novo Nordisk employees and our collaborators across the world. We are very pleased with the results from the program demonstrating that liraglutide will be able to offer benefits to people with type 2 diabetes. We are enthusiastic about the prospect of bringing liraglutide to market after completion of the regulatory process."

About liraglutide, LEAD™ and HbA1c Liraglutide is a once-daily human analogue of the naturally occurring hormone Glucagon-Like Peptide-1 (GLP-1). 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.

The portfolio of LEAD™ studies for liraglutide included around 4,000 patients with type 2 diabetes whose blood glucose is inadequately controlled. The program was comprised of five randomized, controlled, double-blind studies conducted in more than 40 countries.

The LEAD™ 1 and LEAD™ 2 studies investigated the effect of different doses of liraglutide in combination with a single oral antidiabetic drug, glimepiride and metformin respectively.  The LEAD™ 3 study compared the effect of liraglutide with glimepiride when used as monotherapy.  The LEAD™ 4 study investigated the effect of different doses of liraglutide in combination with metformin and rosiglitazone.  The LEAD™ 5 study compared the effect of liraglutide with insulin glargine when used as add-on therapy in patients inadequately controlled by two of the most widely used oral  antidiabetic drugs: metformin and a sulfonylurea (glimepiride). 

Results of the Lead 3 study will be presented at ADA scientific sessions in June.

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