EMA Approves Dupilumab for COPD in Europe

On July 3rd, 2024, pharmaceutical giants Sanofi and Regeneron announced a significant milestone: their jointly developed drug, dupilumab (marketed as Dupixent), has received approval from the European Medicines Agency (EMA). This authorization allows Dupixent to be used in treating adult patients with Chronic Obstructive Pulmonary Disease (COPD) who exhibit high blood eosinophil levels and whose condition remains inadequately managed by standard therapies. These standard therapies include inhaled corticosteroids (ICS), long-acting beta2-agonists (LABA), and long-acting muscarinic antagonists (LAMA) triple therapy, or LABA and LAMA dual therapy when ICS is unsuitable.

This approval stands as a groundbreaking development in the COPD treatment landscape within the European Union. Dupixent is now the first targeted therapy sanctioned for COPD patients, marking a significant advancement in managing this chronic respiratory condition. COPD is a widespread disease marked by airflow obstruction and lung inflammation, severely affecting patients' quality of life. Despite numerous available treatments, COPD patients continue to struggle with frequent acute exacerbations and the associated high healthcare costs.

Dupilumab is a fully human monoclonal antibody that targets and blocks the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13). These cytokines are instrumental in the development of COPD, and their overproduction exacerbates lung inflammation and deterioration of lung function. By inhibiting these pathways, dupilumab reduces inflammation and alleviates COPD symptoms, offering a more targeted and potentially more effective treatment for patients.

During the approval process with the U.S. Food and Drug Administration (FDA), the agency requested a more detailed analysis of the efficacy data derived from the Phase III BOREAS and NOTUS studies. This additional scrutiny has delayed the PDUFA (Prescription Drug User Fee Act) date for Dupixent in the United States, shifting it from the initially scheduled June 27th, 2024, to September 27th, 2024. In response, Sanofi and Regeneron have proactively submitted the necessary additional data in early May, aiming to facilitate the expedited approval of the drug in the U.S.

The approval of Dupixent in Europe introduces a new treatment avenue for COPD patients, promising more targeted and effective management of this challenging condition. This development has the potential to substantially enhance the quality of life for many individuals suffering from COPD.