Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion, recommending marketing authorization 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 mellitus to improve glycemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycemic control.
In both the DUALT I and II Phase 3a trials in the clinical development program, Xultophy achieved an average HbA1c reduction of 1.9%. Among people treated with Xultophy, 81% of those previously treated with oral anti-diabetics and 60% of those previously treated with basal insulin achieved the HbA1c treatment target of 7% 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 hypoglycemia, which was comparable to that of Tresiba, and achieved a reduction in body weight when compared to treatment with basal insulin.
“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,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
Novo Nordisk expects to receive final marketing authorization 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.
Date: July 25, 2014
Source: Novo Nordisk