US approval for Novo Nordisk's Xultophy/IDegLira as diabetes battle hots up

22 November 2016

The US Food and Drug Administration (FDA) has approved Novo Nordisk’s (NOV: N) New Drug Application (NDA) for Xultophy (insulin degludec/liraglutide) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin or liraglutide.

Xultophy, the Danish diabetes giant’s approved brand name for IDegLira in the USA, is a once-daily, single injection fixed combination of long-acting insulin degludec, branded Tresiba, and the GLP-1 analogue liraglutide, labeled Victoza.

In a Phase III trial, Xultophy showed an improvement of glycemic control in adults with type 2 diabetes uncontrolled on liraglutide or basal insulin therapy.

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