1. Dupixent approved in Japan for asthma in children 6-11 years. 2. Demonstrated 54% to 65% reduction in asthma exacerbations. 3. Dupixent improves lung function significantly in pediatric patients. 4. Approval expands treatment options in pediatric asthma population. 5. Dupixent now approved in over 50 countries for asthma treatment.
FAQ
Why Bullish?
The approval enhances Dupixent's market presence significantly, likely boosting REGN's revenues. Historical precedents such as the FDA's approval of similar treatments have led to positive stock movements for Regeneron.
How important is it?
This approval opens a crucial market in Japan for Dupixent, potentially increasing sales. It signifies growth in REGN's strategic product offerings and indicates successful clinical trials.
Why Short Term?
The immediate recognition and marketability of Dupixent in Japan will likely lead to increased sales shortly after market launch. Positive investor sentiment can manifest quickly following news of significant approvals.
Regeneron’s Dupixent® Approved in Japan for Young Asthma Patients
TARRYTOWN, N.Y. and PARIS, Dec. 23, 2025 (GLOBE NEWSWIRE) - Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi have announced that Dupixent® (dupilumab) has received marketing and manufacturing authorization from Japan's Ministry of Health, Labour and Welfare (MHLW). This approval specifically benefits children aged 6 to 11 years diagnosed with severe or refractory bronchial asthma whose conditions remain inadequately controlled with current therapies, thus expanding the drug's availability, which previously applied to patients aged 12 years and older.
Approval Based on Promising Clinical Data
The approval of Dupixent in Japan is supported by comprehensive data from a global Phase 3 trial known as VOYAGE. This study involved children aged 6 to 11 with moderate-to-severe asthma, revealing that Dupixent significantly lowered severe asthma exacerbations by 54% to 65% compared to placebo, whilst improving lung function by 4.68% to 5.32%.
Additionally, further evidence was derived from the EXCURSION trial, which included a sub-study focused exclusively on Japanese pediatric patients. Data indicated that Dupixent not only reduced exacerbation rates but also enhanced lung function over a year of treatment.
Impact of Uncontrolled Asthma on Children
Asthma is among the most prevalent chronic diseases affecting children. Conventional treatments, including inhaled corticosteroids and bronchodilators, often fail to fully alleviate symptoms such as coughing, wheezing, and difficulty breathing. Prolonged uncontrolled asthma can lead to significant complications, including impaired lung development and heightened reliance on potentially harmful systemic corticosteroids.
- Long-term impacts of poor asthma control include reduced lung growth.
- Children may experience difficulties in daily activities, including sleep disturbances and limitations in physical activities.
Broader Indications and Availability of Dupixent
Beyond bronchial asthma, Dupixent is also approved in Japan for various other conditions, including atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria (CSU), and chronic obstructive pulmonary disease (COPD). With its recent approval in Japan, Dupixent has been authorized in over 50 countries for treating asthma in children aged 6 to 11 years.
About Dupixent®
Dupixent is administered via subcutaneous injection and is available in 200 mg and 300 mg pre-filled syringes or pens. Frequency of administration depends on the patient’s weight, with doses delivered either every two or four weeks. This treatment can be self-administered at home or in a clinical setting after appropriate training.
Developed using Regeneron’s proprietary VelocImmune® technology, Dupixent is a fully human monoclonal antibody targeting interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, both pivotal in mediating type 2 inflammation. It is important to note that Dupixent is not categorized as an immunosuppressant.
Regeneron's Dedication to Innovative Treatments
Regeneron is committed to advancing therapies through the ongoing development of Dupixent, which has involved over 60 clinical trials with more than 10,000 patients. The collaboration with Sanofi aims to explore Dupixent's efficacy across various diseases influenced by type 2 inflammation, thereby broadening its potential impact in clinical settings.
Conclusion
With the approval of Dupixent for younger asthma patients in Japan, Regeneron (NASDAQ: REGN) continues to enhance treatment options for children suffering from chronic respiratory conditions. The significant clinical benefits demonstrated in recent studies underscore Dupixent's role in addressing unmet medical needs within this vulnerable population.