Press release
Dupixent® (dupilumab) Approved in China as the First-ever Biologic Medicine for Patients with Chronic Obstructive Pulmonary Disease (COPD)
Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved lung function and also improved health-related quality of life COPD is the most prevalent chronic respiratory disease in China, and is a priority within the government’s Healthy China 2030 public health plan Dupixent is now approved in four indications across respiratory and dermatological diseases in China TARRYTOWN, N.Y. and PARIS, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the National Medical Products Administration (NMPA) in China has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Dupixent for the treatment of COPD has been approved in more than 30 countries worldwide, including the 27 countries in the European Union (EU). “The impact of COPD extends far beyond the patient. Debilitating breathlessness and irreversible lung damage make it difficult for patients to do simple daily tasks, placing a significant burden on family members, the central caregivers in Chinese families,” said Professor Kang Jian, Chair of COPD Branch, Chinese Association of Chest Physicians, CMDA, Respiratory Department of First Hospital of China Medical University. “The approval of Dupixent for COPD in China is critical, as it fills a gap in targeted therapy for the disease and provides clinicians with a new treatment approach. This offers new hope for COPD patients who remain inadequately controlled even after triple therapy, as well as those who care for them.” “One in four people with COPD live in China, and many patients are unable to control their disease with standard of care treatments and experience repeated hospitalizations from exacerbations and debilitating limitations on their quality of life,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer ...