Dupixent® (dupilumab) Approved in the European Union as the First-ever Targeted Therapy for Patients with COPD

Dupixent® (dupilumab), a monoclonal antibody developed by Regeneron Pharmaceuticals in collaboration with Sanofi, has been approved by the European Medicines Agency (EMA) for the treatment of adults with chronic obstructive pulmonary disease (COPD) and raised blood eosinophils, making it the first targeted therapy for this patient population in Europe. The approval is based on the results of two pivotal Phase 3 trials, LIBERTY ASCENT and LIBERTY CHRIS, which demonstrated that Dupixent significantly reduced exacerbations, improved lung function, and enhanced health-related quality of life in patients with severe eosinophilic COPD.

COPD is a progressive and debilitating lung disease characterized by chronic airflow limitation and persistent respiratory symptoms, including cough, shortness of breath, and sputum production. It is primarily caused by long-term exposure to tobacco smoke, air pollution, and other irritants. According to the World Health Organization, approximately 300 million people worldwide suffer from COPD, making it one of the most common respiratory diseases.

Eosinophils are a type of white blood cells that play a crucial role in the immune response, particularly in allergic and inflammatory conditions. In some patients with COPD, eosinophils are overactive, leading to chronic inflammation and exacerbations, which can worsen symptoms and contribute to lung damage.

Dupixent is a monoclonal antibody that selectively inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13), two key cytokines involved in the eosinophilic inflammatory response. By blocking these cytokines, Dupixent reduces eosinophilic inflammation and, consequently, exacerbations, lung damage, and impairment of health-related quality of life.

The LIBERTY ASCENT trial enrolled 512 patients with severe eosinophilic COPD and demonstrated that Dupixent 300 mg every six weeks significantly reduced the annual rate of moderate or severe exacerbations by 53% compared to placebo (p<0.001). The LIBERTY CHRIS trial involved 550 patients and showed that Dupixent improved lung function, as measured by forced expiratory volume in one second (FEV1), by 110 mL (p<0.001) compared to placebo at 24 weeks. Additionally, patients treated with Dupixent reported significant improvements in health-related quality of life, as assessed by the St. George's Respiratory Questionnaire (SGRQ) total score (p<0.001).

The approval of Dupixent marks a significant milestone in the treatment of COPD, as it represents the first new therapy approach for this disease in more than a decade. The targeted therapy is expected to provide a new treatment option for patients with severe eosinophilic COPD, helping to reduce exacerbations, improve lung function, and enhance health-related quality of life.

Regeneron Pharmaceuticals and Sanofi are planning to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Dupixent in the treatment of severe eosinophilic COPD based on these trial results. If approved, Dupixent would become the first targeted therapy for this patient population in the United States as well.

In summary, Dupixent (dupilumab) has been approved by the EMA as the first targeted therapy for adults with severe eosinophilic COPD, making it a significant advancement in the treatment of this debilitating disease. The monoclonal antibody, which selectively inhibits IL-4 and IL-13, has been shown to reduce exacerbations, improve lung function, and enhance health-related quality of life in clinical trials. The approval is expected to provide a new treatment option for patients in Europe, and Regeneron and Sanofi are planning to submit an sNDA to the FDA for Dupixent's use in severe eosinophilic COPD in the United States.