Highlights

  • Japan expands Dupixent asthma approval to children aged 6–11 years
  • Authorization supported by Phase 3 VOYAGE and EXCURSION trial data
  • Approval covers severe or refractory asthma not controlled by existing therapy

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted marketing and manufacturing authorization for Dupixent® (dupilumab) to treat bronchial asthma in children aged 6 to 11 years. The authorization applies to pediatric patients with severe or refractory asthma whose symptoms remain inadequately controlled with existing treatments. This decision extends a prior approval in Japan that covered patients aged 12 years and older.

The latest authorization broadens access to Dupixent within the pediatric asthma population, addressing younger children who continue to experience symptoms despite standard-of-care therapy.

Clinical Trial Evidence Supporting Approval

The approval is based on results from the global Phase 3 VOYAGE trial, which evaluated Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. The data included outcomes from the overall study population and from patients with a type 2 inflammation phenotype, identified by elevated blood eosinophils and/or fractional exhaled nitric oxide.

In VOYAGE, Dupixent, when added to standard asthma therapy, reduced severe asthma exacerbations by 54% to 65% compared with placebo, with statistically significant results. Improvements in lung function ranging from 4.68% to 5.32% were also reported across key patient subgroups.

Additional support came from EXCURSION, an open-label extension of VOYAGE, which included a sub-study involving only Japanese pediatric patients. In this sub-study, Dupixent improved lung function from baseline at 12 weeks and was associated with a low rate of severe asthma exacerbations over one year.

Safety Profile Observed in Studies

Treatment-related adverse events reported in VOYAGE most commonly included injection site reactions such as erythema, edema, and induration. In the EXCURSION study, reported events included fever, oral herpes, eosinophilia, and injection site reactions.

Pediatric Asthma Context

Asthma remains one of the most common chronic diseases affecting children. Some patients continue to experience coughing, wheezing, and breathing difficulties despite inhaled corticosteroids and bronchodilators. Ongoing symptoms and impaired lung function in young children may affect daily activities and, if unaddressed, could have longer-term consequences. Some patients also require repeated courses of systemic corticosteroids, which carry known risks.

Dupixent Availability and Use in Japan

In Japan, Dupixent is available as a 200 mg or 300 mg pre-filled syringe or pen. For children aged 6 to 11 years with asthma, the treatment is administered as a subcutaneous injection every two or four weeks, depending on body weight. Administration may take place in a clinical setting or at home following training by a healthcare professional, with caregivers administering the treatment for children under 12 years of age.

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