Japan Approves Dupixent for COPD, Expanding Treatment Options

In a major development for chronic obstructive pulmonary disease (COPD) treatment, Regeneron Pharmaceuticals and Sanofi have secured approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Dupixent® (dupilumab). This authorization allows Dupixent to be used in adults with COPD that remains uncontrolled despite existing therapies. The approval was backed by data from the BOREAS Phase 3 trial, which showed significant reductions in exacerbations and improved lung function when Dupixent was added to standard-of-care inhaled therapy. These findings, along with results from the NOTUS trial, were recently published in The New England Journal of Medicine, reinforcing Dupixent’s potential in managing COPD.

This milestone expands Dupixent’s approved indications in Japan, where it is already used for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, and chronic spontaneous urticaria (CSU). With this latest approval, Japan joins a growing list of over 45 countries, including all 27 EU nations, recognizing Dupixent as a transformative treatment for COPD. By addressing a significant unmet need, this approval brings new hope to patients struggling with severe, uncontrolled respiratory disease.