The European Commission approved an expanded use for a fixed combination of insulin degludec and liraglutide for adults with type 2 diabetes and renal impairment, Novo Nordisk announced in a press release.
Insulin degludec and liraglutide (Xultophy, Novo Nordisk) is a fixed-ratio combination of a glucagon-like peptide-1 receptor agonist and a basal insulin in one pen; insulin degludec (Tresiba) and liraglutide (Victoza) are both approved agents. The authorization covers all 28 European Union member states, Norway and Iceland.
"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," Andrew Boulton, professor of medicine at the University of Manchester and consultant physician at Manchester Royal Infirmary, said in the release.
The approval is based on data from the LIRA-RENAL phase 3b clinical trial, which examined the efficacy and safety of liraglutide vs. placebo as an add-on to existing diabetes medication in people with type 2 diabetes with moderate renal impairment.
Insulin degludec/liraglutide is approved for the treatment of adults with type 2 diabetes to improve glycemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or basal insulin do not provide adequate glycemic control. The combination is not licensed for the treatment of obesity.