CHMP recommends Victoza for treatment of Type 2 Diabetes and Renal Impairment- Novo Nordisk

The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the use of Victoza (liraglutide) from Novo Nordisk, 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.

The CHMP recommendation for Victoza was based on efficacy and safety data from the LIRA-RENAL phase IIIb clinical trial. The 26-week, double-blind, randomised, controlled study investigated the efficacy and safety of Victoza compared with placebo when added to pre-existing oral antidiabetic treatment, insulin or a combination thereof in adults with Type 2 Diabetes and moderate Renal Impairment.