Novo Nordisk Gets EU Nod for Obesity DrugBy
Novo Nordisk has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) for the use of SaxendaÂ® (liraglutide 3 mg) for the treatment of obesity.
Saxenda, the intended brand name of liraglutide 3 mg, is a once-daily glucagon-like peptide-1 (GLP-1) analogue, with 97% homology to naturally occurring human GLP-1, a hormone involved in appetite regulation.The CHMP positive opinion recommends that Saxenda will be indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with specified body mass indices and with at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or Type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.
Saxenda was approved by the US Food and Drug Administration (FDA) in December 2014. or its new drug application for Saxenda (liraglutide 3 mg), a once-daily human glucagon-like peptide-1 (GLP-1) analog for the treatment of obesity.
Saxenda has the same active ingredient (liraglutide) as the company’s Type II diabetes drug, Victoza, but is dosed differently (3 mg compared to 1.8 mg for Victoza). Victoza is one of the company’s top-selling drugs with 2013 revenues of DKK 11.6 billion ($2.0 billion).
Source: Novo Nordisk