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Home Industry News Novo Nordisk receives CHMP backing for Tresiba label update

Novo Nordisk receives CHMP backing for Tresiba label update

3rd October 2017

Novo Nordisk has announced that its diabetes drug Tresiba has had a proposed label update recommended for approval by European regulators.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has endorsed an EU label update for Tresiba to include results from the DEVOTE trial on severe hypoglycaemia.

In this study, it was shown that 27 percent fewer patients receiving Tresiba experienced an episode of severe hypoglycaemia compared to those on insulin glargine U100, resulting in a 40 percent overall rate reduction of total episodes of adjudicated severe hypoglycaemia.

Additionally, patients in the Tresiba-treated group experienced a 53 percent relative reduction in the rate of nocturnal severe hypoglycaemia.

Mads Krogsgaard Thomsen, executive vice-president and chief science officer of Novo Nordisk, said: "Our ambition is to help people with type 2 diabetes reach their treatment goals and at the same time reduce their risk of severe hypoglycaemia."

Tresiba was approved by the European Commission in January 2013 and has since been made available for sale in more than 80 countries globally.

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