Novo Nordisk is preparing to launch Xultophy in its first countries in the European Union in the first half of next year after gaining European Commission approval for the diabetes treatment.
Xultophy (formerly known as IDegLira) combines the Danish pharma company’s Tresiba (insulin degludec) with its market-leading GLP-1 analogue Victoza (liraglutide) in a once-daily injection.
The new treatment is indicated for adults with type 2 diabetes to help them 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.
Mads Krogsgaard Thomsen, chief science officer of Novo Nordisk, said: “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.”
Xultophy’s European approval was based on late-stage studies showing it can avoid common side effects of insulin treatment while still lowering blood sugar levels.
The EC’s decision follows the Swiss license Novo received for Xultophy earlier this month and its 2012 Japanese approval.
This success is in stark contrast to the product’s fortunes in the US where the FDA has yet to approve the Tresiba part of the combination, delaying Novo’s launch not only of Tresiba as a monotherapy and Xultophy, but also its combination treatment Ryzodeg (which adds insulin aspart to Tresiba).