Novo Nordisk’s Saxenda Demonstrates Significant Weight Loss in Children Aged 6-12 in Phase III Trial
Efficacy in Children:
Novo Nordisk's Saxenda (liraglutide) has shown significant weight loss in children aged 6-12 with obesity, achieving a 5.8% reduction in body mass index (BMI) over 52 weeks in a Phase IIIa trial.
Comparison to Placebo:
The trial, which involved 82 children, found that those treated with Saxenda had a significantly greater reduction in BMI compared to the placebo group, which saw only a 1.6% decrease.
Safety Profile:
Adverse events were common but balanced between the Saxenda and placebo groups, with 89% of Saxenda-treated children and 88% of placebo-treated children reporting such events.
Regulatory Approval:
Saxenda is currently approved by the US FDA for obesity management in adolescents aged 12 and above. Novo Nordisk plans to use the Phase III SCALE Kids trial data to expand the Saxenda label to include obese children over 6 years old.
Market Context:
The obesity market is projected to reach $100 billion by 2030, making these treatments significant revenue opportunities for companies like Novo Nordisk and Eli Lilly.
Future Developments:
Novo Nordisk is also exploring the use of its obesity treatments in cardiovascular contexts and is developing a combination therapy, CagriSema (cagrilintide/semaglutide), for various cardiometabolic conditions.