Novo Nordisk's Xultophy gains expanded label in Europe

Global diabetes care leader Novo Nordisk (NOV: N) says that the European Commission has approved the expanded use of Xultophy (insulin degludec/liraglutide), the first once-daily combination of a long-acting basal insulin (Tresiba [insulin degludec]) and a glucagon-like peptide-1 (GLP-1) receptor agonist (Victoza [liraglutide]) in one pen, in adults with type 2 diabetes and moderate renal impairment (CrCL 30-59 mL/min).

The authorization covers all 28 European Union member states, Norway and Iceland. Renal impairment is a challenging and common long-term complication of type 2 diabetes that requires frequent monitoring of blood glucose levels and kidney function. Depending on age, duration of diabetes and blood glucose control, up to 40% of people with type 2 diabetes will develop some degree of renal impairment.

"The label expansion of Xultophy (insulin degludec/liraglutide) is a very important milestone as the current treatment options are very limited for people with type 2 diabetes, and especially for those living with obesity, who also suffer from moderate renal impairment," said Andrew Boulton, Professor of Medicine at the University of Manchester and Consultant Physician at Manchester Royal Infirmary.