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Novo says three year wait for Tresiba safety data

Trial will start this year comparing insulin’s cardiovascular safety to that of Lantus

Novo Nordisk headquarters

It will be two to three years before Novo Nordisk will be able to present data from a cardiovascular safety study for its insulin degludec Tresiba in people with diabetes.

In its financial results statement for the first half of 2013, the Danish pharma company said the study will compare Tresiba to rival insulin Lantus from Sanofi in a double-blind trial involving 7,500 patients with diabetes. Novo expects the study to be initiated by the end of 2013.

Lack of clarity on the cardiovascular safety of Tresiba was one of the sticking points behind the US Food and Drug Administration's (FDA) decision not to recommend the insulin in February this year, with the agency on high alert after the controversy surrounding GlaxoSmithKline's Avandia (rosiglitazone).

The decision was criticised in some quarters, with leading healthcare professionals in diabetes questioning the FDA's strict stance considering Tresiba has been recommended in Europe, Switzerland and Japan.

Since February, an FDA panel has also recommended that the FDA take a more lenient view on Avandia following a reassessment of trial data, although this is unlikely to affect the Tresiba outcome.

As it stands, Tresiba, which offers a more flexible dosing method to its big rival Lantus, was able to provide a “modest sales contribution” for the first half of the year, according to Novo.

This helped sales of modern insulins increase by 15 per cent for the period to 18.62bn Danish krone.

It was Novo's other big diabetes product Victoza that saw the most impressive growth, however, with sales up 32 per cent to 5,555m Danish Krone, primarily driven by increased uptake in the US and Europe.

Overall, total company sales were up by 14 per cent to 41.4bn Danish Krone, while net profit was up by 27 per cent to 12.7bn Danish krone.

With this strong performance, Novo raised its sales expectations for the year from growth of 9 to 11 per cent to growth of 11 to 13 per cent.

Article by
Thomas Meek

9th August 2013

From: Sales

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