T_Dia
05-26-2008, 05:09 PM
Novo Nordisk has submitted a new drug application to the FDA in the US as well as a marketing authorization application to the European Medicines Agency 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 III trials constituting the Lead 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. Novo Nordisk expects to file for marketing approval of liraglutide in Japan in the third quarter of 2008.
Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk, said: "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."
http://www.datamonitor.com.
Full Article (http://www.tradingmarkets.com/.site/news/Stock%20News/1614196/).
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 III trials constituting the Lead 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. Novo Nordisk expects to file for marketing approval of liraglutide in Japan in the third quarter of 2008.
Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk, said: "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."
http://www.datamonitor.com.
Full Article (http://www.tradingmarkets.com/.site/news/Stock%20News/1614196/).