FDA approves Xultophy 100/3.6 (insulin degludec plus liraglutide) to treat type 2 diabetes.-Novo Nordisk

Novo Nordisk announced that the FDA has approved the New Drug Application (NDA) for Xultophy 100/3.6.(iDegLira in the EU). Xultophy 100/3.6 is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily). Xultophy 100/3.6, the approved brand name for IDegLira in the US, is a once-daily, single injection fixed combination of long-acting insulin degludec (Tresiba ) and the GLP-1 analogue liraglutide (Victoza).

In the DUAL phase III clinical trial programme, Xultophy 100/3.6 consistently showed an improvement of glycaemic control in adults with type 2 diabetes uncontrolled on liraglutide or basal insulin therapy. For adults inadequately controlled on insulin glargine U100, treatment with Xultophy 100/3.6 demonstrated a reduction in HbA1c of 1.7% after 26 weeks. Xultophy 100/3.6 can be taken at the same time each day with or without food and will be available in a prefilled pen.