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Xultophy gets European approval for type 2 diabetes patients with renal impairment

An insulin-based combination therapy has received European approval for use in adults with type 2 diabetes and moderate renal impairment.
The fixed-dose combination drug, called Xultophy, is manufactured by Novo Nordisk and combines Tresiba (insulin degludec) with a glucagon-like-peptide-1 (GLP-1) receptor agonist Victoza (liraglutide) in a once-daily dose.
The European Commission (EC) has allowed the expanded use of Xultophy in all 28 European Union member states plus Norway and Iceland.
This combined type 2 diabetes medication is indicated for patients suffering from renal impairment, which represents up to 40 per cent of cases (depending on age, duration of diabetes and blood glucose control).
Treatment options for people with type 2 diabetes and renal impairment were until now very limited.
The approval is based on data from the clinical trial LIRA-RENAL, which involved more than 3,500 people with type 2 diabetes and demonstrated the efficacy and safety of liraglutide as an add-on to the existing diabetes medication Tresiba in patients with moderate renal impairment.
The combination treatment has also been shown to significantly improve glycemic control in combination with oral glucose-lowering medicines when these, alone or combined either with a GLP-1 receptor agonist or insuli, do not suffice.
In addition to that, Xultophy (known as IDegLira in USA) greatly simplifies the administration of the two drugs at the right dosage, which is now enabled by one single injection at any time of the day via a pre-filled pen.
Xultophy was first granted marketing authorisation by the EC and was approved in Switzerland back in September 2014.
Earlier this year, the Endocrinologic and Metabolic Drug Advisory Committee also voted unanimously for the US FDA to allow IDegLira to be used by people with type 2 diabetes on the other side of the Atlantic, but an authorisation has yet to be granted.

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