Novo Nordisk Announces FDA Approval of Saxenda (Liraglutide) for Chronic Weight Management in Adolescents Aged 12-17 with Obesity

On December 4, Novo Nordisk announced that the U.S. FDA had approved an update to the prescribing information for its liraglutide injection (brand name Saxenda) for the treatment of obesity in adolescents aged 12–17 years with a body weight above 60 kg and a body mass index (BMI) of 30 kg/m² or greater, as an adjunct to a reduced-calorie diet and increased physical activity.

Data from a Phase 3 clinical trial published earlier this year in The New England Journal of Medicine supported the recent approval of liraglutide for the treatment of adolescent obesity. The clinical trial results showed that after 56 weeks of treatment, liraglutide as an adjunct to lifestyle therapy resulted in a 4.29% reduction in BMI compared with a 0.35% increase in the placebo group, thereby meeting the study’s primary endpoint. Furthermore, at 56 weeks, 43.3% of adolescents in the liraglutide group achieved a BMI reduction of ≥5% (vs. 18.7% in the placebo group), and 26.1% achieved a BMI reduction of ≥10% (vs. 8.1% in the placebo group).

Over the past two decades, the global prevalence of overweight and obesity among children and adolescents has doubled, rising from one in ten to one in five. Worldwide, more than 124 million children and adolescents are affected by obesity. Studies have shown that when both parents are overweight, 80% of their children will become obese.

Liraglutide is a once-daily injectable glucagon-like peptide-1 (GLP-1) analog that shares 97% structural homology with endogenous human GLP-1, a hormone secreted in response to food intake. Similar to human GLP-1, liraglutide regulates blood glucose by enhancing satiety and fullness while reducing hunger, thereby decreasing caloric intake. In 2014, the U.S. Food and Drug Administration (FDA) approved liraglutide as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a body mass index (BMI) ≥30 kg/m², or a BMI ≥27 kg/m² in the presence of at least one weight-related comorbidity.

References:

[1] FDA approves Saxenda® for the treatment of obesity in adolescents aged 12-17. Retrieved 2020-12-05, from https://www.prnewswire.com/news-releases/fda-approves-saxenda-for-the-treatment-of-obesity-in-adolescents-aged-12-17-301186800.html

Source: Jike Pharmaceutical News

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