Dupixent (dupilumab) Becomes the First Biologic Medicine Approved in Japan for Chronic Obstructive Pulmonary Disease (COPD)
Saturday, March 29, 2025
Regeneron Pharmaceuticals, Inc. and Sanofi have received marketing and manufacturing authorisation from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Dupixent (dupilumab) as a treatment for adults with chronic obstructive pulmonary disease (COPD) that is not adequately controlled with existing therapy.
The approval is based on data from the BOREAS Phase 3 trial, which assessed the addition of Dupixent to the highest standard inhaled therapy. Most participants were already on triple therapy, while some were on double therapy if inhaled corticosteroids were not suitable. The study showed that Dupixent significantly reduced exacerbations and improved lung function compared to a placebo. The safety profile was consistent with previous findings, with injection site reactions being the most commonly reported side effect. Results from BOREAS and the NOTUS Phase 3 trial were published in The New England Journal of Medicine.
Beyond COPD, Dupixent is already approved in Japan for conditions such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), prurigo nodularis, and chronic spontaneous urticaria (CSU). The medicine has also been approved for COPD treatment in over 45 countries, including the 27 European Union (EU) member states.
COPD is a chronic lung disease that progressively reduces lung function and is a major cause of death worldwide. Common symptoms include persistent cough, excessive mucus production, and breathlessness, which can impact daily activities and lead to sleep disturbances, anxiety, and depression. The disease also places a significant health and economic burden due to frequent exacerbations that often require corticosteroids or antibiotics. Smoking and exposure to harmful airborne particles are key risk factors, and even those who quit smoking may still experience disease progression. Despite using triple inhaled therapy, nearly half of COPD patients continue to suffer from exacerbations, particularly those with elevated eosinophil levels who are at a higher risk of hospitalisation.
Regeneron and Sanofi aim to improve COPD treatment by exploring different types of inflammation that contribute to disease progression. This includes clinical research on two biologic medicines: Dupixent and itepekimab.
Dupixent is a first-in-class biologic that targets interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, focusing on patients with type 2 inflammation. Itepekimab is a fully human monoclonal antibody that inhibits interleukin-33 (IL-33), a key driver of inflammation in COPD.
Itepekimab is currently undergoing clinical trials for COPD in two Phase 3 studies, but its safety and effectiveness have not yet been reviewed by any regulatory authority.
Source: globenewswire.com
