Novo Nordisk Gains Positive Opinion from EMA Advisory Committee for New Indication for Victoza

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion for the use of Novo Nordisk’s 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 (EU) will be able to prescribe Victoza, a once-daily human glucagon-like peptide-1 (GLP-1) analog, to adults with Type 2 diabetes and moderate renal impairment without dose adjustments. Victoza had 2013 sales of DKK 11.6 billion ($2.0 billion).

Victoza is a GLP-1 analog with an amino-acid sequence 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza works by stimulating the beta cells to release insulin and suppressing glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza is associated with a low rate of hypoglycemia. In addition, Victoza reduces body weight and body fat mass through mechanisms involving reduced appetite and lowered food intake. Victoza is not approved for weight management or for use in people who do not have Type 2 diabetes.

Victoza was launched in the EU in 2009 and is commercially available in more than 70 countries. In Europe, Victoza is indicated for treatment of adults with Type 2 diabetes to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. In the US, Victoza was approved in January 2010 as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2 diabetes.

Source: Novo Nordisk

Leave a Reply

Your email address will not be published. Required fields are marked *