Dupixent Approved in Japan for Asthma in Children Aged 6 to 11
The Japanese Ministry of Health has granted marketing authorization for Dupixent (dupilumab) to treat bronchial asthma in children aged 6 to 11 with severe or refractory forms, according to a joint statement from Sanofi and Regeneron. This decision expands the existing indication in Japan for patients aged 12 and older.
Clinical Study Results
The authorization is based on the results of the global phase 3 VOYAGE study, which evaluated dupilumab in children aged 6 to 11 with moderate to severe uncontrolled asthma, the statement indicates. In this study, the treatment added to standard care reduced severe exacerbations by 54% to 65% in the overall population, with an improvement in lung function ranging from 4.68% to 5.32% across patient groups, compared to placebo. The EXCURSION study, an open-label extension of VOYAGE that included a sub-study exclusively conducted among Japanese pediatric patients, also supported this approval. In this sub-study, the medication improved lung function at 12 weeks compared to baseline and generated a low rate of severe exacerbations over a year, the company specifies. The most common adverse effects were injection site reactions, fever, oral herpes, and eosinophilia.
Asthma in Children
Asthma is among the most common chronic diseases in children, the statement recalls. Despite treatments with inhaled corticosteroids and bronchodilators, some children continue to experience severe symptoms such as coughing, wheezing, and breathing difficulties. Impairment of lung function in young children can lead to lasting consequences, including reduced lung growth and persistent airway obstruction if not managed early, the group emphasizes. Patients may also require multiple courses of systemic corticosteroids, which carry significant risks. Uncontrolled asthma can disrupt daily activities such as sleep, schooling, and sports, the company adds.
About Dupixent
Dupixent is a fully human monoclonal antibody that inhibits the signaling of interleukins 4 and 13, and is not an immunosuppressant, the statement clarifies. In Japan, the medication is already approved for certain patients with atopic dermatitis, chronic rhinosinusitis with nasal polyps, nodular prurigo, chronic spontaneous urticaria, and chronic obstructive pulmonary disease. The treatment is now available for children aged 6 to 11 with asthma in pre-filled syringes or pens of 200 mg or 300 mg, administered by subcutaneous injection every two or four weeks depending on weight. In children under 12, administration at home must be performed by a caregiver, the group indicates. Dupixent is approved in 50 countries for the treatment of asthma in children aged 6 to 11, and over 1.3 million patients worldwide are treated with this medication, according to the statement.
