Press release
Dupixent® (dupilumab) Approved as the First-ever Biologic Medicine in Japan for Patients with Chronic Obstructive Pulmonary Disease (COPD)
Following recent approvals in the EU, China and the U.S., this approval was based on pivotal Phase 3 results in adults with elevated eosinophils Approval
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Following recent approvals in the EU, China and the U.S., this approval was based on pivotal Phase 3 results in adults with elevated eosinophils Approval marks the first new treatment approach for COPD in more than a decade in Japan and the sixth approved indication for chronic diseases with underlying type 2 inflammation TARRYTOWN, N.Y. and PARIS, March 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. The approval in Japan was based on data from the landmark pivotal BOREAS Phase 3 trial. The trial evaluated Dupixent added to background maximal standard-of-care inhaled therapy (with nearly all patients on triple therapy or double therapy if inhaled corticosteroids were contraindicated) in adults with uncontrolled COPD and elevated blood eosinophils. In the trial, Dupixent significantly reduced exacerbations and improved lung function compared to placebo. Safety results in the trial were generally consistent with the known safety profile of Dupixent in its approved indications. The adverse event most commonly reported with Dupixent was injection site reaction. Results from BOREAS and the replicate NOTUS Phase 3 trial were published in The New England Journal of Medicine. In addition to COPD, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and chronic spontaneous urticaria (CSU). Dupixent for the treatment of COPD has been approved in more than 45 countries worldwide, including the 27 member countries of the European Union (EU). About COPDCOPD is a chronic respiratory disease that damages the lungs and causes progressive lung function decline, and is the fourth leading cause of death worldwide. Symptoms include persistent cough, excessive mucus production and shortness of breath that may impair the ability to perform routine daily activities, which may lead to sleep disturbances, anxiety and depression. COPD is also associated with a significant health and economic burden due to recurrent acut...