Novo receives positive opinion on Xultophy® (IDegLira)

A drug combining Novo Nordisk’s long-acting insulin degludec with its Type 2 diabetes treatment Victoza has been recommended for approval in Europe.

The  Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for Xultophy® for the treatment of Type 2 diabetes mellitus in adults.

Xultophy® is the intended brand name for IDegLira, the first once-daily single injection combination of Tresiba® (insulin degludec) and Victoza® (liraglutide), developed for the treatment of Type 2 diabetes. The CHMP positive opinion recommends that Xultophy® will be indicated for the treatment of adults with Type 2 diabetes 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.

In both the DUALTM I and II phase 3a trials in the clinical development programme, Xultophy® achieved an average HbA1c reduction of 1.9 per cent. Among people treated with Xultophy®, 81 per cent of those previously treated with oral anti-diabetics and 60 per cent of those previously treated with basal insulin achieved the HbA1c treatment target of 7 per cent as defined by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA). People treated with Xultophy® experienced a low rate of hypoglycaemia, which was comparable to that of Tresiba®, and achieved a reduction in body weight when compared to treatment with basal insulin.

Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer of Novo Nordisk, said: “We are excited about the positive opinion for Xultophy® from the CHMP. We believe that Xultophy® represents a new treatment 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.”

Novo Nordisk expects to receive final marketing authorisation from the European Commission within approximately three months. Subject to the Commission’s approval and completion of pricing and reimbursement discussions, Novo Nordisk expects to launch Xultophy® in the first European markets in the first half of 2015.