CHMP recommends alteration to indication of Xultophy in type 2 diabetes.- Novo Nordisk.
The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for Xultophy (insulin degludec plus liraglutide), from Novo Nordisk A/S. The CHMP adopted a change to the existing indication as follows: Xultophy is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to other oral medicinal products for the treatment of diabetes.
Comment: 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.
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