EU Approves Novo Nordisk's Drug For Type 2 Diabetes Treatment

July 3, 2009 11:08 a.m. EST

London, United Kingdom (AHN) - The European Commission has granted marketing authorization to a Novo Nordisk A/S (NYSE: NVO)'s drug for the treatment of type 2 diabetes in adults, amid higher competition in the GLP-1 field.

Novo Nordisk, a Danish pharmaceutical company, revealed the news on Friday that it will now be able to market and sell Victoza in the 27 European Union member states.

"This is an important milestone for Novo Nordisk and for the treatment of type 2 diabetes," Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said in a statement today.

Victoza is the brand name approved in Europe for liraglutide, the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes, the company said.

In clinical studies involving more than 6,500 people with type 2 diabetes, Victoza has been shown to have a significant blood glucose-lowering effect and lead to weight loss, while having a low risk of hypoglycaemia, according to Thomsen.

"On this background, we are convinced that Victoza is a valuable new treatment option for people with type 2 diabetes," he said.

The country had applied for the approval in Europe in April, just weeks after the U.S. Food and Drug Administration failed to finalize a decision to introduce the drug in the U.S. due to a split vote.

Novo Nordisk said it will launch Victoza in the UK, Germany and Denmark during the summer and in other European markets during the second half of 2009 and throughout 2010.

The company reportedly said that it plans to reapply for authorization from the FDA soon and expects to get an approval before the end of this year.

The marketing approval in Europe does not change Novo Nordisk's expectations for the company's financial results for 2009, the company said today.

Novo Nordisk will provide an update on the expectations for the company's financial results for 2009 on Aug. 6.