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EU approval for Novo Nordisk's Victoza

The European Commission has granted marketing authorisation for Novo Nordisk's Victoza for the treatment of type 2 diabetes in adults

The European Commission (EU) has granted marketing authorisation for Novo Nordisk's Victoza for the treatment of type 2 diabetes in adults. The authorisation covers all 27 European Union member states.

Victoza (liraglutide) is a relatively new kind of diabetes drug class known as GLP-1 analogues. In contrast to conventional treatment with insulin, the drug doesn't risk pushing blood glucose dangerously low and it also helps patients to lose weight.

Mads Krogsgaard Thomsen, chief scientific officer of the Danish pharmaceutical company, said: "In clinical studies involving more than 6,500 people with type 2 diabetes, Victoza has shown to have a significant blood glucose-lowering effect and lead to weight loss while having a low risk of hypoglycaemia. We are convinced that Victoza is a valuable new treatment option for people with type 2 diabetes."

Analysts and investors have seen significant sales potential for Victoza which in April was issued a positive opinion by the EU's Committee for Medicinal Products for Human Use, only weeks after a Food & Drug Administration (FDA) panel reached a split vote on whether to recommend it for launch in the US.

It is still uncertain whether Victoza will be launched in the US although Novo Nordisk is in talks with the FDA and hopes for approval "within months".

The Danish pharmaceutical company will launch Victoza in the UK, Germany and Denmark during the summer and in the other European markets during the second half of 2009 and throughout 2010.

The European marketing approval does not change Novo Nordisk's expectations for the company's financial results for the first six months of 2009, as the authorisation was already reflected in the share price. At the close of trading, shares were down 0.5 per cent against a broader 1 per cent drop in the Copenhagen market.

6th July 2009

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