Xultophy®▼ (insulin degludec/liraglutide) Receives European Approval for Use in Adults with Type 2 Diabetes and Moderate Renal Impairment

GATWICK, UK, September 1, 2016 /PRNewswire/ --

This material is intended for UK medical media only.

For journalistic assessment and preparation before publication.

Novo Nordisk, a world leader in diabetes care, announced that the European Commission (EC) has approved the expanded use of Xultophy® (insulin degludec/liraglutide), the first 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.  

Renal impairment is a challenging and common long-term complication of type 2 diabetes that requires frequent monitoring of blood glucose levels and kidney function. Depending on age, duration of diabetes and blood glucose control, up to 40% of people with type 2 diabetes will develop some degree of renal impairment.^[1]

"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," said Andrew Boulton, Professor of Medicine at the University of Manchester and Consultant Physician at Manchester Royal Infirmary.

The approval is based on data from the LIRA-RENAL phase 3b 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.^[2]

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.^[3]

*Insulin degludec/liraglutide is not licensed for the treatment of obesity.

About Xultophy®  

Xultophy® is a once-daily single injection combination of Tresiba® (insulin degludec), a once-daily basal insulin analogue, and Victoza® (liraglutide), a once-daily human GLP-1 receptor agonist.^[3] The maximum dose of Xultophy® is 50 dose steps (equivalent to 50 units of insulin degludec and 1.8 mg of liraglutide). Xultophy® is being investigated in the DUAL clinical trial programme, which includes two phase 3a and a number of phase 3b trials, encompassing more than 3,500 people with type 2 diabetes. Xultophy® was granted marketing authorisation by the European Commission on 18 September 2014 and approved in Switzerland on 12 September 2014.^[3]

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.co.uk.

▼: This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See http://www.MHRA.gov.uk/yellowcard for how to report side effects.

Further Information

Media:

Stephen Cull
+44-7584-447-280,
scul@novonordisk.com

Mario Christodoulou
+44-7789-507-812,
mciu@novonordisk.com

Investors:

Peter Hugreffe Ankersen
+45-3075-9085,
phak@novonordisk.com

Melanie Raouzeos
+45-3075-3479,
mrz@novonordisk.com

Daniel Bohsen
+45-3079-6376,
dabo@novonordisk.com

References

1. Bailey CJ DC. Diabetes therapies in renal impairment. British Journal of Diabetes and Vascular Disease 2012; 12:167-171

2. Davies MJ, Bain SC, Atkin SL, et al. Efficacy and safety of liraglutide versus placebo as add-on to glucose-lowering therapy in patients with type 2 diabetes and moderate renal impairment (LIRA-RENAL): a randomized clinical trial. Diabetes Care . 2016; 39:222-230

3. Xultophy® summary of product characteristics. Available at: https://www.medicines.org.uk/emc/medicine/29493#DOCREVISION Last accessed: August 2016.