Dupixent approved as first biologic medicine in Japan for COPD patients
Ella Day | April 2, 2025 | News story | Research and Development |Â Â COPD, Chronic Diseases, Regeneron, Sanofi, biotech, respiratory diseaseÂ
The Ministry of Health, Labour and Welfare in Japan has authorised marketing and manufacturing of Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults, whose disease is inadequately controlled by existing therapy.
The approval in Japan was based on data from the BOREAS phase 3 study conducted by Sanofi and Regeneron. It found that Dupixent significantly reduced exacerbations of symptoms and improved lung function compared to placebo. The study analysed whether Dupixent added to background maximal standard-of-care inhaled therapy in adults with uncontrolled COPD and elevated blood eosinophils. The results of the trial were published in The New England Journal of Medicine.
Dupixent for the treatment of COPD has been approved in more than 45 countries worldwide, including the 27 member countries of the EU.
In addition to COPD, Dupixent is approved in Japan in certain patients with other conditions, namely atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and chronic spontaneous urticaria (CSU).
COPD is a chronic respiratory disease that damages the lungs and causes progressive lung function decline. Symptoms include persistent cough, excessive mucus production and shortness of breath. Patients are often treated with triple inhaler therapy, known as single-inhaler triple therapy (SITT). About half of COPD patients continue to experience exacerbations of symptoms despite being on triple inhaled therapy. Patients with COPD and elevated eosinophils have an increased risk of symptom exacerbations and COPD-related hospitalisations within a year.
Sanofi is an international pharma and healthcare company, providing vaccination and treatment services. Regeneron is a biotech company which develops and commercialises treatment for serious diseases. Both are motivated to support and develop treatments for COPD by researching Dupixent.
Ella Day
2/4/2025
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