CHMP approves Victoza for use in adults with type 2 diabetes, moderate renal impairment

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Victoza^® (liraglutide) in adults with type 2 diabetes and moderate renal impairment. Once the European Commission approves the label expansion, physicians in the European Union will be able to prescribe Victoza^®, the once-daily human glucagon-like peptide-1 (GLP-1) analogue, to adults with type 2 diabetes and moderate renal impairment without dose adjustments.

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.

“Renal impairment is very common in patients with type 2 diabetes, and the choice of glucose-lowering therapies available to people with both conditions is limited”, said Melanie Davies, professor of Diabetes Medicine and honorary consultant, Diabetes Research Centre, University of Leicester, UK and clinical trial investigator. “This label update gives physicians an additional treatment option to help their patients with type 2 diabetes and moderate renal impairment achieve glycaemic control.”

The CHMP recommendation for Victoza^® was based on efficacy and safety data from the LIRA-RENAL phase 3b clinical trial.