CHMP recommends Novo Nordisks’s Saxenda for the treatment of obesity in adolescentsMarch 29, 2021
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that the use of Novo Nordisks’s Saxenda is expanded for the treatment of obesity in adolescents aged 12–17 years.
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 ≥30 kg/m2 for adults and a body weight above 60 kg, in combination with healthy eating and increased physical activity, Novo Nordisk said.
Saxenda is already indicated for weight management in adults with a BMI ≥30 kg/m2, or ≥27 kg/m2 with one or more weight‑related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity.
Over the last 20 years, the global prevalence of obesity in children and adolescents has doubled from 1 in 10 to 1 in 5, and now more than 124 million children and adolescents live with obesity globally.
The CHMP opinion is based on the results of a phase 3 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 company said.
The CHMP positive opinion is now referred to the European Commission, the governing body granting approval for the marketing of medicines in the EU. Novo Nordisk expects to receive the European Commission decision on the Saxenda label update within a few months.