Tokyo, Japan – December 23, 2025
Sanofi and Regeneron have received regulatory approval in Japan for Dupixent (dupilumab) to treat bronchial asthma in children aged 6 to 11 years whose symptoms are not adequately controlled by standard therapies.
The authorization is supported by global Phase 3 clinical trial data, demonstrating significant reductions in severe asthma exacerbations and improvements in lung function in this younger patient population. This approval extends Dupixent’s use beyond older children and adults, providing a new treatment option for pediatric patients with moderate-to-severe asthma.
Sanofi and Regeneron emphasized their commitment to expanding access to innovative therapies for children worldwide, aiming to address unmet medical needs in pediatric asthma and improve long-term disease management.
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