Press Release: Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD

Core Insights - Dupixent (dupilumab) has been approved in Japan as the first biologic medicine for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose condition is not adequately controlled with existing therapies [1][3] - The approval is based on the BOREAS phase 3 study, which demonstrated that Dupixent significantly reduced exacerbations and improved lung function compared to placebo [2][9] - Dupixent is already approved for various conditions in Japan, including atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis, and has received approvals in over 45 countries worldwide for COPD [3][11] Group 1: Dupixent Approval and Clinical Data - The approval in Japan was supported by data from the BOREAS phase 3 study, which involved adults with uncontrolled COPD and elevated blood eosinophils [2] - Dupixent was shown to significantly reduce exacerbations and improve lung function compared to placebo, with safety results consistent with its known profile [2][9] - The most common adverse event reported was injection site reaction [2] Group 2: COPD Overview - COPD is a chronic respiratory disease that leads to progressive lung function decline and is the fourth leading cause of death globally [4] - Symptoms include persistent cough, excessive mucus production, and shortness of breath, which can impair daily activities and lead to sleep disturbances, anxiety, and depression [4] - Approximately half of COPD patients continue to experience exacerbations despite being on triple inhaled therapy, with those having elevated eosinophils at increased risk for exacerbations and hospitalizations [4] Group 3: Dupixent and Type-2 Inflammation - Dupixent is a first-in-class biologic that inhibits interleukin-4 (IL4) and interleukin-13 (IL13) signaling pathways, targeting a specific population with type-2 inflammation [6][9] - The Dupilumab development program has been assessed in over 60 clinical studies involving more than 10,000 patients with chronic diseases driven by type-2 inflammation [12] - Sanofi and Regeneron are also investigating another biologic, itepekimab, which targets interleukin-33 (IL33) and is currently under clinical investigation for COPD [5][7]