BAGSVAERD, Denmark I September 18, 2014 I Novo Nordisk today announced that the European Commission has granted marketing authorisation for Xultophy® for the treatment of type 2 diabetes mellitus in adults. The authorisation covers all 27 European Union member states.

Xultophy® is the brand name for IDegLira, the first once-daily single injection combination of insulin degludec (Tresiba®) and liraglutide (Victoza®). Xultophy® is indicated for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycaemic control.

“We believe that Xultophy® represents a new paradigm with the potential to transform how type 2 diabetes is treated. We look forward to making the product available to people with type 2 diabetes in Europe,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

Xultophy® was approved in Switzerland on 12 September 2014. Novo Nordisk expects to launch Xultophy® in the first European countries in the first half of 2015.

About Xultophy®
Xultophy® is a once-daily, single injection combination product consisting of insulin degludec (Tresiba®), a once-daily basal insulin analogue with an ultra-long duration of action, and liraglutide (Victoza®), the once-daily human GLP-1 analogue.

Xultophy® has shown consistent results in improving glycaemic control in insulin-naïve people with type 2 diabetes as well as those uncontrolled on basal insulin. For people uncontrolled on basal insulin therapy, Xultophy® has demonstrated a significant reduction in HbA1C of 1.9% with a mean weight loss of 2.7 kg and a low rate of hypoglycaemia comparable to that of insulin degludec.

Novo Nordisk submitted the application for marketing authorisation for Xultophy® in the EU on 31 May 2013.

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Novo Nordisk is a focused healthcare company.

Novo Nordisk is a healthcare company and a world leader in diabetes care.

In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society.

SOURCE: Novo Nordisk