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Home Industry News Novo Nordisk applies for European liraglutide approval

Novo Nordisk applies for European liraglutide approval

29th May 2008

Novo Nordisk (NN) has applied for the European and US approval of its diabetes treatment liraglutide, it has announced.

The drug is a once-daily human GLP-analogue for the treatment of people with type 2 diabetes.

NN says its application documentation shows the findings of its development programme, where use of liraglutide was combined with an improved diet and exercise and, in some cases, with common antidiabetic medications.

Around 4,200 of the 6,500 people who took part in the development programme received liraglutide.

The majority of people were included in the phase III trials where liraglutide was compared with three widely used classes of antidiabetic drugs – sulfonylurea, glitazone and basal insulin.

NN found a “statistically significant benefit of liraglutide” on the primary endpoint, which was the lowering of blood glucose, and on the secondary endpoint, weight loss.

Executive vice-president and chief science officer Mads Krogsgaard Thomsen said: “This is a major achievement for NN ? we are enthusiastic about the prospect of bringing liraglutide to market after completion of the regulatory process.”

Type 2 diabetes, increasing in the UK and other developed countries, is linked to activity, diet and obesity, the NHS says.

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