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Novo Nordisk receives US FDA approval


Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Xultophy 100/3.6. 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 3 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.

“We are pleased with the approval of Xultophy 100/3.6 and look forward to launching it in the US in the first half of 2017”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “We believe Xultophy 100/3.6 offers significant benefits and is an important and convenient treatment option especially for people not achieving sufficient glycaemic control with basal insulin”.

The approval follows the recommendation of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), which voted 16-0 in favour of an approval of Xultophy 100/3.6 for the treatment of adults with type 2 diabetes, at its meeting on 24 May 2016.