Press Release: Dupixent approved in the EU as the first-ever targeted therapy for patients with COPD

Title: Dupixent Approved in the EU as First-Ever Targeted Therapy for COPD: A New Milestone in Respiratory Medicine

On July 3, 2024, Sanofi, a leading global biopharmaceutical company, announced that the European Commission (EC) has granted marketing authorization for its monoclonal antibody, Dupixent (dupilumab), as a new treatment option for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype and a history of exacerbations. This approval marks a significant milestone in respiratory medicine, making Dupixent the first-ever targeted therapy for patients with COPD in Europe (Sanofi, 2024).

COPD is a progressive lung disease characterized by persistent respiratory symptoms and airflow limitation. It is primarily caused by long-term exposure to lung irritants, most notably cigarette smoke (World Health Organization, 2023). The disease is typically managed through bronchodilators, corticosteroids, and other symptomatic treatments (National Heart, Lung, and Blood Institute, 2023). However, targeted therapies that specifically address the underlying causes of COPD have been lacking until now.

The European approval of Dupixent is based on data from two pivotal Phase 3 studies, SOLOIST-COPD 1 and 2 (Sanofi, 2024). These studies demonstrated that Dupixent significantly reduced the rate of moderate-to-severe exacerbations compared to placebo in patients with COPD and an eosinophilic phenotype (defined as a sputum eosinophil count = 2% or = 150 cells/µL or blood eosinophils = 150 cells/µL) (Sanofi, 2024). The treatment effect was consistent across all pre-defined subgroups, including smoking status, baseline lung function, and history of exacerbations (Sanofi, 2024).

The safety results from both studies were generally consistent with the known safety profile of Dupixent in its approved indications, which include atopic dermatitis and asthma (Sanofi, 2024). The most common side effects across indications include injection site reactions, conjunctivitis, and upper respiratory tract infections (Sanofi, 2024).

The approval of Dupixent for COPD is a game-changer in respiratory medicine, offering a new treatment option for a specific patient population that has not had a targeted therapy available to them until now (Sanofi, 2024). This approval is expected to have a significant impact on the management of COPD and may lead to improved outcomes for eligible patients.

References:

National Heart, Lung, and Blood Institute. (2023). Chronic obstructive pulmonary disease (COPD). Retrieved July 3, 2024, from https://www.nhlbi.nih.gov/health-topics/copd

Sanofi. (2024, July 3). Press Release: Dupixent approved in the EU as the first-ever targeted therapy for patients with COPD. Retrieved July 3, 2024, from https://www.marketscreener.com/quotestock/news/Press-Release-Dupixent-approved-in-the-EU-as-the-first-ever-targeted-therapy-for-patients-with-COPD-47290427?utm_medium=RSS&utm_content=20240703

World Health Organization. (2023). Chronic obstructive pulmonary disease (COPD). Retrieved July 3, 2024, from https://www.who.int/news/fact-sheets/detail/copd/en/

Sanofi. (2024). Dupixent (dupilumab) European Commission approval for COPD. Retrieved July 3, 2024, from https://www.sanofi.com/en/media/press-releases/dupixent-dupilumab-european-commission-approval-for-copd/2024