Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY) yesterday announced that Japan's Ministry of Health, Labor and Welfare has approved Dupixent for children aged 6 to 11 years with severe or refractory bronchial asthma whose symptoms are inadequately controlled with existing therapy.
Asthma in children is a chronic inflammatory disease of the airways that can cause recurrent wheezing, coughing, and difficulty breathing. Severe cases often require hospitalization and can significantly impair quality of life. Dupixent (dupilumab), a fully human monoclonal antibody, works by inhibiting IL-4 and IL-13, two key drivers of type 2 inflammation.The approval was based on results from a global Phase 3 program in children with severe asthma, which demonstrated that Dupixent significantly reduced asthma 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 show improved lung function in this young patient group in a randomized Phase 3 study.
Dupixent is already approved in the U.S. and other markets for multiple indications, including moderate-to-severe atopic dermatitis in adults and children, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis.
This latest approval expands Dupixent's reach in pediatric asthma, reinforcing its role as a cornerstone therapy across allergic and inflammatory diseases.
Financially, Dupixent continues to be a major growth driver. In the third quarter of 2025, global net sales recorded by Sanofi rose 27% year-over-year to $4.86 billion from $3.81 billion in 2024, underscoring its commercial strength.
Regeneron's share of profits also increased, underscoring the strength of the collaboration, which has been pivotal in scaling Dupixent worldwide.
REGN has traded between $476.49 and $790.98 over the past year. The stock closed yesterday's trading at $779.36, up 1.48%.
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