CHMP positive opinion on Victoza in type 2 diabetes patients with moderate renal impairment

The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Victoza (liraglutide), manufactured by Danish insulin giant Novo Nordisk (NOV: N), in the treatment of adult type 2 diabetes with moderate renal impairment.

This means that physicians in the European Union will be able to prescribe this already blockbuster drug in this indication without dose adjustments once the European Commission has approved the label expansion.

The recommendation is based on efficacy and safety data from the LIRA-RENAL trial, a Phase III, 26-week, double-blind randomized control study comparing Victoza to placebo when added to pre-existing oral antidiabetic treatment, insulin or a combination, in adults with type 2 diabetes and moderate renal impairment. The addition of once-daily Victoza versus placebo in adults with type 2 diabetes and moderate renal impairment showed statistically significantly greater reduction in mean HbA1c (-1.05% versus -0.38%) and body weight (-2.41 kg vs -1.09 kg).