The European Commission has granted marketing authorisation for Novo Nordisk's 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.

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 per cent 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.