22.01.2015 22:01:34

Novo Nordisk Gets Positive CHMP Opinion For Obesity Drug Saxenda

(RTTNews) - Novo Nordisk A/S (NVO) said Thursday that that the Committee for Medicinal Products for Human Use under the European Medicines Agency adopted a positive opinion for the use of Saxenda 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 an initial Body Mass Index of >= 30 kg/m(2) (obese), or >= 27 kg/m? to < 30 kg/m? (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia, hypertension, dyslipidaemia or obstructive sleep apnoea.

Last month, the US Food and Drug Administration had approved the New Drug Application for Saxenda.

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