Dupixent® (dupilumab) Receives Approval in Japan as the First Biologic Medicine for Chronic Obstructive Pulmonary Disease (COPD)
Friday, March 28, 2025
Regeneron Pharmaceuticals, Inc. and Sanofi have announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted marketing and manufacturing authorisation for Dupixent® (dupilumab) to treat adults with chronic obstructive pulmonary disease (COPD) who do not have adequate control with existing therapies.
The approval is based on findings from the BOREAS Phase 3 trial, which assessed Dupixent alongside the standard inhaled therapy. Most participants were on either triple therapy or double therapy if inhaled corticosteroids were not suitable. The trial showed that Dupixent significantly reduced disease flare-ups and improved lung function compared to a placebo. The safety results were in line with the medicine's known profile, with injection site reactions being the most commonly reported side effect. Findings from both the BOREAS trial and the NOTUS Phase 3 trial have been published in The New England Journal of Medicine.
Beyond COPD, Dupixent is also 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 received approval for COPD treatment in over 45 countries, including all 27 European Union (EU) member states.
COPD is a long-term respiratory condition that damages the lungs and leads to a decline in lung function. It is the fourth leading cause of death worldwide. Symptoms include persistent coughing, excessive mucus production, and breathlessness, which can interfere with daily activities and contribute to sleep problems, anxiety, and depression. The disease places a significant health and economic burden due to frequent flare-ups requiring systemic corticosteroids or antibiotics. Smoking and exposure to harmful airborne particles are key risk factors, and even individuals who quit smoking may still experience progressive lung damage. Around half of COPD patients continue to have flare-ups despite using triple inhaled therapy. Those with elevated eosinophils face a higher risk of exacerbations and hospitalisation.
Regeneron and Sanofi are working towards improving COPD treatment by studying how different types of inflammation contribute to disease progression. Their research includes the clinical evaluation of two biologic medicines: Dupixent and itepekimab.
Dupixent is a first-in-class biologic that blocks the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, targeting individuals with type 2 inflammation. Itepekimab, a fully human monoclonal antibody, inhibits interleukin-33 (IL-33), which triggers and amplifies inflammation in COPD.
Itepekimab is currently undergoing clinical trials in two Phase 3 studies for COPD. Its safety and effectiveness have not yet been reviewed by regulatory authorities.
Source: regeneron.com
