Sanofi Announces Positive Phase III Results for Dupixent in Children Aged 6-11 with Moderate-to-Severe Asthma

Text | Baihuawen

On October 13, Sanofi announced that Dupixent (dupilumab) met the primary and key secondary endpoints in a pivotal Phase III clinical trial evaluating its efficacy in children aged 6 to 11 years with moderate-to-severe asthma. Dupixent is also currently the only biologic agent demonstrated to improve lung function in children in a randomized Phase III study.

It is estimated that approximately 75,000 children aged 6–11 years in the United States have moderate-to-severe asthma. Despite receiving standard therapies such as inhaled corticosteroids (ICS), these patients continue to experience symptoms including cough and dyspnea, and remain at risk for severe asthma exacerbations. Furthermore, long-term use of ICS can cause significant adverse effects in pediatric patients, while frequent hospitalizations and emergency department visits disrupt school attendance and daily activities.

This randomized, double-blind, placebo-controlled Phase III clinical trial, codenamed LIBERTY ASTHMA VOYAGE, aims to evaluate the efficacy and safety of Dupixent in combination with standard therapy for pediatric patients with moderate-to-severe asthma. The primary endpoint is the annualized rate of severe asthma exacerbations in two prespecified populations: patients with eosinophils (EOS) ≥300 cells/μL and those with type 2 inflammation biomarkers (FeNO ≥20 ppb or EOS ≥150 cells/μL).

The results showed that patients treated with Dupixent experienced a 65% and 59% reduction in the annualized rate of severe asthma exacerbations, respectively, compared to the placebo group. Compared to baseline, lung function in the Dupixent treatment group improved by 10.15 and 10.53 percentage points, respectively, whereas the placebo group showed improvements of 4.83 and 5.32 percentage points. The safety profile was consistent with previous findings.