Japan Approves Dupixent® (Dupilumab) For Children Aged 6–11 With Moderate-To-Severe Bronchial Asthma

Regeneron Pharmaceuticals, Inc. 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 with severe or refractory disease whose symptoms are not adequately controlled with existing therapies. This approval expands the previous indication in Japan, which covered patients aged 12 years and older.

The approval is supported by data from the VOYAGE Phase 3 trial, which evaluated Dupixent in children aged 6 to 11 with uncontrolled moderate-to-severe asthma, including those with a type 2 inflammation phenotype, characterized by elevated blood eosinophils and/or increased fractional exhaled nitric oxide. Results showed that adding Dupixent to standard-of-care asthma therapy significantly reduced severe exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% compared with placebo. 

Additional support came from EXCURSION, an open-label extension of VOYAGE that included a sub-study of Japanese pediatric patients. In this sub-study, Dupixent improved lung function after 12 weeks and maintained a low rate of severe exacerbations over one year. The most common treatment-related side effects reported were injection site reactions in VOYAGE, and fever, oral herpes, eosinophilia, and injection site reactions in EXCURSION.

Asthma is among the most common chronic conditions in children. Even with standard treatments such as inhaled corticosteroids and bronchodilators, many children continue to experience symptoms like coughing, wheezing, and difficulty breathing. Persistent asthma can affect lung growth, airway function, and overall quality of life, often requiring multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled asthma may also interfere with daily activities, including sleep, school attendance, and physical activity.

Beyond asthma, Dupixent is approved in Japan for the treatment of certain patients with atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria (CSU), and chronic obstructive pulmonary disease (COPD). Globally, Dupixent has been approved in 50 countries for the treatment of asthma in children aged 6 to 11 years.