Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that the use of Saxenda® is expanded for the treatment of obesity in adolescents aged 12–17 years.1
Over the last 20 years, the global prevalence of obesity in children and adolescents has doubled from 1 in 10 to 1 in 5,2,3 and now more than 124 million children and adolescents live with obesity globally.4 Adolescents with obesity are more likely to develop weight-related complications, like diabetes and heart disease at a younger age,5 therefore it is important that adolescents with obesity have the necessary support to effectively manage their weight.
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.1 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.6
“The global rise in adolescent obesity is a public health issue and poses a severe challenge for adolescents’ living with obesity due to the limited treatment options available,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “The recommendation from the CHMP for the approval of Saxenda® for adolescents is an important step towards offering adolescents with obesity a treatment option to effectively manage their weight when healthy eating and physical activity alone is not enough.”
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 safety profile was similar to that observed in adults with the most common adverse events being gastro-intestinal in nature. 7
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.
Reference
1. CHMP. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021 | European Medicines Agency (europa.eu).
2. UNICEF. The state of the world’s children 2019. Available at: https://www.unicef.org/media/
3. Abarca-Gómez L, Abdeen ZA, Hamid ZA, et al. Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128·9 million children, adolescents, and adults. The Lancet. 2017; 390:2627-2642.
4. World Health Organization. Obesity and Overweight Factsheet no. 311. Available at: http://www.who.int/
5. World Health Organization. Childhood overweight and obesity. Available at: https://www.who.int/
6. EMA. Saxenda® (liraglutide 3 mg) summary of product characteristics. Available at: https://www.ema.europa.eu/en/
7. Kelly AS, Auerbach P, Barrientos-Perez M, et al. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. N Engl J Med. 2020; 382:2117-2128.
