Written By: Pharmacally Medical News Desk
Japan’s Ministry of Health, Labour and Welfare has granted marketing and manufacturing approval for Dupixent (dupilumab) to treat children aged 6 to 11 years with severe or refractory bronchial asthma, whose symptoms are not adequately controlled with existing therapies. This decision expands the country’s earlier approval of Dupixent for patients aged 12 years and older.
Dupixent is a fully human monoclonal antibody that targets and inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signalling pathways. These two cytokines play central roles in type 2 inflammation, which drives many cases of moderate-to-severe asthma. By blocking this signalling, Dupixent reduces airway inflammation, helping to prevent asthma exacerbations and improve lung function.
The regulatory decision in Japan was based on data from the Phase 3 VOYAGE trial (NCT02948959), which evaluated Dupixent in children aged 6 to 11 with uncontrolled moderate-to-severe asthma. In this global study, Dupixent demonstrated:
A reduction in severe asthma exacerbations by 54% to 65% compared with placebo across different patient subgroups.
Improved lung function, measured by changes in pulmonary performance metrics (FEV1), with increases of about 4.7% to 5.3% versus placebo.
- Benefits were seen in the overall trial population and in children with a type 2 inflammation phenotype, defined by elevated blood eosinophils and/or fractional exhaled nitric oxide (FeNO).
Additionally, data from EXCURSION (NCT03560466), an open-label extension of VOYAGE that included a sub-study of exclusively Japanese pediatric patients, further supported the approval. These extension data showed sustained clinical benefit and reinforced safety and tolerability in real-world-like follow-up.
Dupixent’s safety profile in children was consistent with what has been seen in older age groups. In the trials supporting approval in VOYAGE, the most commonly reported treatment-related adverse events were injection site reactions, including erythema, edema, and induration. In EXCURSION (the extension study), the most frequent events included fever, oral herpes, eosinophilia, and injection site reactions such as erythema and induration.
Dupixent stands out as the first biologic therapy to show statistically significant improvement in lung function in children aged 6 to 11 years in a randomized Phase 3 trial. This milestone highlights its potential to address unmet needs in pediatric asthma, where conventional treatments may fail to control symptoms fully.
In Japan, Dupixent is available as a 200 mg or 300 mg pre-filled syringe or pre-filled pen. Dosing schedules for children aged 6 to 11 are weight-based and typically administered every two or four weeks. Subcutaneous injection can be given in a clinic or at home after appropriate caregiver training. For home administration in this age group, a caregiver must perform the injection.
Beyond this new pediatric asthma indication in Japan, Dupixent is approved in many countries for several type 2 inflammatory diseases, including Atopic dermatitis, Chronic rhinosinusitis with nasal polyposis (CRSwNP), Chronic spontaneous urticaria (CSU), and Chronic obstructive pulmonary disease (COPD). In some markets, Dupixent is already approved for asthma in children aged 6 to 11, and global regulatory filings continue in multiple regions. Because of its multi-disease action, it received the prestigious Prix Galien Award in 2025.
This approval gives healthcare providers and families in Japan a new, evidence-based option for managing severe pediatric asthma. By targeting central drivers of the disease, Dupixent has the potential to reduce hospitalizations, improve breathing, and enhance quality of life for young patients struggling with uncontrolled symptoms
References
Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma, 23 December 2025, https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-japan-children-aged-6-11-years
Evaluation of Dupilumab in Children with Uncontrolled Asthma (VOYAGE), ClinicalTrials.gov ID NCT02948959, https://www.clinicaltrials.gov/study/NCT02948959
Leonard B. Bacharier et al, Dupilumab in Children with Uncontrolled Moderate-to-Severe Asthma, N Engl J Med 2021;385:2230-2240, DOI: 10.1056/NEJMoa2106567
Assessment of the Safety and Efficacy of Dupilumab in Children with Asthma (Liberty Asthma Excursion), ClinicalTrials.gov ID NCT03560466, https://clinicaltrials.gov/study/NCT03560466
Bacharier LB et al, Assessment of long-term safety and efficacy of dupilumab in children with asthma (LIBERTY ASTHMA EXCURSION): an open-label extension study. Lancet Respir Med. 2024 Jan;12(1):45-54. Doi: 10.1016/S2213-2600(23)00303-X. Epub 2023 Nov 10. PMID: 37956679.