EMA approves Dupixent as first biologic for COPD with elevated eosinophils

The European Medicines Agency (EMA) has granted approval to Dupixent (dupilumab) as a novel add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by elevated blood eosinophils. This marks the first time Dupixent, jointly developed by Sanofi and Sanofi and Regeneron, is approved for this specific patient group within the European Union, setting a precedent for its use globally. Further regulatory submissions are currently under review in the US, China, and Japan.

The approval was influenced by the positive outcomes of the phase 3 BOREAS and NOTUS studies, which demonstrated significant reductions in COPD exacerbations and notable improvements in lung function and health-related quality of life. These studies, published in The New England Journal of Medicine, have positioned Dupixent as the first biologic treatment targeting an underlying cause of COPD, specifically addressing type 2 inflammation indicated by elevated blood eosinophil counts.

Tonya Winders, President & CEO of the Global Allergy & Airways Patient Platform, highlighted the profound impact of COPD on patient quality of life, emphasizing that the approval of Dupixent represents a significant breakthrough after more than a decade of stagnant therapeutic developments. “This approval marks a new era of disease management, offering a beacon of hope for patients and caregivers by introducing an innovative treatment option to manage this progressive and irreversible disease effectively,” she stated.

Paul Hudson, CEO of Sanofi, expressed enthusiasm about the new treatment’s potential. “Patients with uncontrolled COPD have long awaited a novel therapeutic approach. With today’s approval of Dupixent, we can change the treatment landscape for over 200,000 patients across the EU, reducing exacerbations and improving lung function substantially,” Hudson noted.

The efficacy of Dupixent was confirmed through the BOREAS and NOTUS trials, where it was administered bi-weekly alongside standard care including inhaled corticosteroids (ICS), long-acting beta2-agonists (LABA), and long-acting muscarinic antagonists (LAMA). Results showed a 30% to 34% reduction in moderate or severe COPD exacerbations over 52 weeks. Improvements in lung function were observed as early as two to four weeks and sustained over a year.

Regarding safety, the profile of Dupixent in these studies was consistent with its known effects across other indications. The most common side effects included injection site reactions, conjunctivitis, and arthralgia. Notably, Dupixent is not an immunosuppressant, which is a significant advantage in treating respiratory conditions.

George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer at Regeneron, reflected on the broader implications of this approval: “The approval of Dupixent for COPD is a long-awaited turning point for those struggling with daily activities due to severe respiratory symptoms. This first-in-class therapy has demonstrated unprecedented improvements in exacerbations, lung function, and quality of life, redefining treatment expectations in COPD management.”

This landmark approval is expected to transform the therapeutic landscape for COPD, particularly for those with evidence of type 2 inflammation. As Dupixent rolls out across the European Union and potentially other major markets pending further approvals, it stands to offer a new standard of care that could significantly alter the management of a disease that affects millions worldwide.