Press release
Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma
Approval based on global Phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung function (by
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Approval based on global Phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung function (by 4.68% to 5.32%) compared to placebo Dupixent is the first and only biologic medicine to demonstrate improved lung function in this young patient group in a randomized Phase 3 trial, and inhibits IL-4 and IL-13, two key and central drivers of type 2 inflammation TARRYTOWN, N.Y. and PARIS, Dec. 23, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease whose symptoms are inadequately controlled with existing therapy. This expands the previous approval in Japan in this indication for patients aged 12 years and older. The approval in Japan is based on data from the overall population and those with a type 2 inflammation phenotype (defined by raised blood eosinophils and/or fractional exhaled nitric oxide) in VOYAGE, a global Phase 3 trial evaluating Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Additionally, data from EXCURSION, an open-label extension of VOYAGE that included a sub-study of exclusively Japanese pediatric patients supported the approval. In the VOYAGE trial, Dupixent added to standard-of-care asthma therapy significantly reduced severe exacerbations (by 54% to 65%, p","length":2434,"tagName":"div"}]