EU approves expanded indication for Xultophy (insulin degludec / liraglutide) in type 2 diabetes with moderate renal impairment- Novo Nordisk
The European Commission (EC) has approved the expanded use of Xultophy (insulin degludec/liraglutide), from Novo Nordisk, a 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 authorisation covers all 28 European Union member states, Norway and Iceland.
The approval is based on data from the LIRA-RENAL phase IIIb clinical trial, which examined the efficacy and safety of liraglutide versus placebo as an add-on to existing diabetes medication in people with type 2 diabetes with moderate renal impairment.
Comment: Insulin degludec/liraglutide is approved 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 a GLP-1 receptor agonist or basal insulin do not provide adequate glycaemic control.
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