Sanofi and Regeneron's Dupixent approved in Japan for children aged 6 to 11 with asthma
Japan's Ministry of Health, Labour and Welfare has approved Dupixent (dupilumab) for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease. The approval expands prior authorization for patients aged 12 and older.
Sanofi and Regeneron announced that Dupixent (dupilumab) has received marketing and manufacturing authorization in Japan for the treatment of bronchial asthma in children aged 6 to 11 years. This approval applies to children with severe or refractory disease whose symptoms are inadequately controlled with existing therapies, expanding the previous approval for patients aged 12 and older.
The Japanese authorization is based on data from a global Phase 3 study, which demonstrated that Dupixent significantly reduced severe exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% compared to placebo in children aged 6 to 11 years. Dupixent, a biologic medicine that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), is shown to improve lung function in this young patient group. Data from a sub-study involving Japanese pediatric patients also supported the approval, showing improved lung function and a low rate of severe asthma exacerbations.
Asthma is a common chronic disease in children, and uncontrolled symptoms can significantly impact daily life, including schooling and physical activity. Impaired lung function in young children can lead to potentially long-lasting effects if not addressed early. Dupixent is also approved in Japan for other conditions, including atopic dermatitis and chronic rhinosinusitis with nasal polyps.
Dupixent is administered as a subcutaneous injection, available in 200 mg or 300 mg pre-filled syringes or pens. Dosing is every two or four weeks based on weight. It can be administered in a clinical setting or at home by a caregiver after appropriate training.