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Novo enrols first patient in Tresiba cardiovascular trial

Milestone comes as diabetes-focused company reports solid growth
Novo Nordisk headquarters 

Novo Nordisk announced last week that the first patient has been enroled in its trial to assess the cardiovascular safety of its insulin Tresiba.

The initiative of the DEVOTE study is a major step for the company as it looks to provide the safety data needed to obtain the approval of Tresiba in the US after it was knocked back by the Food and Drug Administration (FDA) last year.

Announcing the news in its financial report for the first nine months of 2013, Novo said it anticipates interim data to be available within two to three years.

“With the initiation of DEVOTE we have passed a significant milestone in the process of making Tresiba available for people with diabetes in the US,” said the company's president and CEO Lars Rebien Sørensen.

Despite its rejection in the US, Tresiba is posting encouraging revenues elsewhere, helping the company's modern insulins business grow by 15 per cent.

This is expected to growth further following recent launches in Sweden and India.

Other strong performers included Novo's GLP-1 therapy Victoza (liraglutide), which managed a 28 per cent growth in sales to reach 8.40bn Danish krone (about €1.12bn) for the period.

Novo also has plans to market the drug as a treatment for obesity if it wins approval.

Growth in these products helped Novo's total sales increase by 13 per cent to 61.9bn Danish krone (about €8.30bn) for the first three quarters of 2013.

Operating profit for the company was up 17 per cent to 24.1bn Danish krone (about €3.23bn).

Novo said it expects high single-digit growth in sales and operating profit for 2014

Article by
Thomas Meek

4th November 2013

From: Sales



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