Saxenda® recommended for approval by European Medicines Agency committee for the treatment of obesity in adolescents aged 12-17 years

BAGSVÆRD, Denmark, March 26, 2021 /PRNewswire/ -- 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.

About the phase 3 trial (NCT02918279)

The trial investigated the safety and efficacy of Saxenda^® (liraglutide 3.0 mg or maximum tolerated dose) compared to placebo for weight management in 251 adolescents (aged 12–17 years) living with obesity as an adjunct to lifestyle therapy. The trial included a 12-week run-in period of lifestyle therapy, a 56-week treatment period (including dose escalation over 4 to 8 weeks) on Saxenda^® or placebo and a 26-week follow-up period without Saxenda^® or placebo. All participants received lifestyle therapy beginning with the run-in period and during the 56-week treatment period and 26-week follow-up period.⁷ The evaluation of Saxenda^® in the paediatric population was part of the Paediatric Investigation Plan (PIP) for Saxenda^®, submitted and agreed upon with the EMA Paediatric Committee (PDCO).^8,9

About Saxenda^®

Saxenda^® (liraglutide 3.0 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1,^6,10 a hormone that is released in response to food intake.¹¹ Like human GLP-1, Saxenda^® is believed to work in areas of the brain involved in appetite regulation, including the hypothalamus.¹² Saxenda^® for use in adults with obesity was evaluated in the SCALE (Satiety and Clinical Adiposity – Liraglutide Evidence) clinical trial programme. Since launch in 2015, more than 1.5 million patients have been treated with Saxenda^® globally.¹

About obesity

Obesity is a chronic and progressive disease that requires long-term medical management.^13,14 One common misunderstanding is that it is a disease of willpower, when in fact there is underlying biology that prevents people from maintaining long-term weight loss.¹⁵ Obesity is influenced by a variety of factors, including genetics, altered appetite signals, behaviour as well as the surrounding environment.¹⁵ It is a disease that is associated with at least 60 other health conditions.¹⁶

About adolescent obesity

Adolescents with obesity are more likely to develop weight-related complications, like diabetes and cardiovascular diseases, at a younger age.⁵ Just like other chronic diseases, obesity requires long-term management.^13,14 80% of adolescents who live with obesity are likely to go on to also have obesity as adults.¹⁷ Globally, more than 124 million children and adolescents have obesity.⁴

About Novo Nordisk

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 45,000 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

References

1. Novo Nordisk. Data on file.
2. UNICEF. The state of the world's children 2019. Available at: https://www.unicef.org/media/60806/file/SOWC-2019.pdf^[1]. Last accessed: March 2021.
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/mediacentre/factsheets/fs311/en/^[2]. Last accessed: March 2021.
5. World Health Organization. Childhood overweight and obesity. Available at: https://www.who.int/dietphysicalactivity/childhood/en/^[3]. Last accessed: March 2021.
6. EMA. Saxenda® (liraglutide 3 mg) summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/saxenda-epar-product-information_en.pdf^[4]. Last accessed: March 2021.
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.
8. EMA. Paediatric investigation plans. Available at: https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans^[5]. Last accessed: March 2021.
9. EMA. On the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Saxenda). Available at: https://www.ema.europa.eu/en/documents/pip-decision/p/0154/2016-ema-decision-15-june-2016-acceptance-modification-agreed-paediatric-investigation-plan_en.pdf^[6]. Last accessed: March 2021.
10. Novo Nordisk Canada. Saxenda^® (liraglutide 3 mg) Canada Product Monograph. Available at: http://www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/OurProducts/PDF/Saxenda_PM_English.pdf^[7]. Last accessed: March 2021.
11. Orskov C, Wettergren A and JJ H. Secretion of the incretin hormones glucagon-like peptide-1 and gastric inhibitory polypeptide correlates with insulin secretion in normal man throughout the day. Scandinavian Journal of Gastroenterology. 1996; 31:665-670.
12. FDA. Saxenda® (liraglutide 3 mg) prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206321s007lbl.pdf^[8]. Last accessed: March 2021.
13. American Medical Association. A.M.A Adopts New Policies on Second Day of Voting at Annual Meeting. Obesity as a Disease. Available at: http://news.cision.com/american-medical-association/r/ama-adopts-new-policies-on-second-day-of-voting-at-annual-meeting,c9430649^[9]. Last accessed: March 2021.
14. Bray GA, Kim KK, Wilding JPH, et al. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev. 2017; 18:715-723.
15. Wright SM and Aronne LJ. Causes of obesity. Abdom Imaging. 2012; 37:730-732.
16. HE Bays, W McCarthy, S Christensen, et al. Obesity Algorithm, presented by the Obesity Medicine Association. Available at: https://obesitymedicine.org/obesity-algorithm/^[10]. Last accessed: March 2021.
17. Lifshitz F. Obesity in Children. J Clin Res Pediatr Endocrinol. 2008; 1:53-60.

References

1. ^{^} https://www.unicef.org/media/60806/file/SOWC-2019.pdf (www.unicef.org)
2. ^{^} http://www.who.int/mediacentre/factsheets/fs311/en/ (www.who.int)
3. ^{^} https://www.who.int/dietphysicalactivity/childhood/en/ (www.who.int)
4. ^{^} https://www.ema.europa.eu/en/documents/product-information/saxenda-epar-product-information_en.pdf (www.ema.europa.eu)
5. ^{^} https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans (www.ema.europa.eu)
6. ^{^} https://www.ema.europa.eu/en/documents/pip-decision/p/0154/2016-ema-decision-15-june-2016-acceptance-modification-agreed-paediatric-investigation-plan_en.pdf (www.ema.europa.eu)
7. ^{^} http://www.novonordisk.ca/content/dam/Canada/AFFILIATE/www-novonordisk-ca/OurProducts/PDF/Saxenda_PM_English.pdf (www.novonordisk.ca)
8. ^{^} https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206321s007lbl.pdf (www.accessdata.fda.gov)
9. ^{^} http://news.cision.com/american-medical-association/r/ama-adopts-new-policies-on-second-day-of-voting-at-annual-meeting,c9430649 (news.cision.com)
10. ^{^} https://obesitymedicine.org/obesity-algorithm/ (obesitymedicine.org)