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news.The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Novo Nordisk's Victoza (liraglutide), to treat adults with type 2 diabetes and moderate renal impairment.
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Victoza (liraglutide) is a once-daily human the human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1.
It works by stimulating the beta cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high.
With this positive opinion, physicians in the European Union (EU) will be able to prescribe Victoza this drug in this indication without dose adjustments once the European Commission approves the label expansion.
The recommendation is based on efficacy and safety data from the 26-week, double-blind randomized control LIRA-RENAL Phase IIIb clinical trial comparing Victoza to placebo when added to pre-existing oral anti-diabetic treatment, insulin or a combination, in these adults.
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 and body weight.
University of Leicester professor of Diabetes Medicine and honorary consultant, Diabetes Research Centre and clinical trial investigator Melanie Davies said: "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.
"This label update gives physicians an additional treatment option to help their patients with type 2 diabetes and moderate renal impairment achieve glycaemic control."