CHMP recommends expanded approval for Saxenda in obesity.- Novo Nordisk

Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that the use of Saxenda (liraglutide) is expanded for the treatment of obesity in adolescents aged 12–17 years.The CHMP opinion is based on the results of a phase III trial published last year in the New England Journal of Medicine, which demonstrated a significant reduction in Body Mass Index (BMI) Standard Deviation Score (SDS), and reduction in BMI, body weight and other weight?related endpoints in adolescents with obesity, when using Saxenda as an adjunct to lifestyle therapy. The safety profile was similar to that observed in adults with the most common adverse events being gastro-intestinal in nature.Comment: If approved, Saxenda will be the first EU-approved treatment for obesity in adolescents. Saxenda would be approved for the treatment of adolescents with obesity, with an initial body mass index (BMI) corresponding to at least 30 kg/m2 for adults and a body weight above 60 kg, in combination with healthy eating and increased physical activity. Saxenda is already indicated for weight management in adults with a BMI of at least 30 kg/m2, or at least 27 kg/m2 with one or more weight?related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity.