EMA Approves Sanofi/Regeneron's Dupixent for Uncontrolled COPD in Adults

Sanofi and Regeneron’s Dupixent (dupilumab) has received approval from the European Medicines Agency (EMA) as an additional maintenance treatment for chronic obstructive pulmonary disease (COPD). This approval targets adults with uncontrolled COPD characterized by elevated blood eosinophils, making Dupixent the first targeted therapy for COPD in the European Union and the first new treatment option for this disease in over a decade.

The approval pertains to patients who are currently being treated with an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or those using a LABA/LAMA combination when ICS is unsuitable.

COPD is a long-term respiratory condition that leads to a gradual decline in lung function. Symptoms include persistent coughing, excessive mucus production, and shortness of breath, which can significantly hinder daily activities. According to Sanofi and Regeneron, there are about 220,000 COPD patients in the EU who might be eligible for Dupixent treatment. This therapy is a fully human monoclonal antibody that blocks the interleukin-4 and interleukin-13 pathways.

The EMA’s decision follows a recommendation from its human medicines committee and is based on positive outcomes from the late-stage BOREAS and NOTUS trials. These studies involved adults with uncontrolled COPD showing evidence of type 2 inflammation. In both trials, Dupixent met the primary endpoint by significantly reducing the rate of moderate or severe acute COPD exacerbations compared to placebo. Moreover, improvements in lung function were sustained for 52 weeks, and patients also experienced better health-related quality of life, as measured by the St. George’s Respiratory Questionnaire.

Paul Hudson, the CEO of Sanofi, expressed his satisfaction with the EMA’s decision, stating, “Patients with uncontrolled COPD have been waiting for a new treatment approach for many years, so we are thrilled to bring to market the first biologic to target an underlying cause of this devastating disease to reduce COPD exacerbations and improve lung function.”

Dupixent is already approved for various other conditions, including specific forms of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. Additionally, regulatory submissions for the use of Dupixent in treating COPD are under review by other regulatory bodies globally, including in the United States.

In summary, the recent approval of Dupixent by the EMA marks a significant milestone in COPD treatment. This new therapy offers hope for many patients who have long awaited a more effective treatment option, potentially improving their lung function and overall quality of life.