FDA Approves Dupixent as Add-On Therapy for Eosinophilic COPD

In a significant step forward for treating chronic obstructive pulmonary disease (COPD), the U.S. Food and Drug Administration (FDA) has authorized the use of Dupixent (dupilumab) as an additional maintenance treatment for adults with COPD who have an eosinophilic phenotype and whose symptoms are inadequately controlled with standard therapies. This approval introduces a new treatment option for patients who struggle to manage their condition despite using maximum inhaled therapy.

The FDA’s decision was based on data from two pivotal phase 3 studies, BOREAS and NOTUS, which involved over 1,800 participants. These trials found that adding Dupixent to existing COPD treatments significantly lowered the frequency of moderate to severe exacerbations. Specifically, in one trial, Dupixent led to a 30% reduction in exacerbations, while the other trial reported a 34% reduction. The trials also demonstrated improvements in lung function, measured by forced expiratory volume (FEV1), that were sustained over a 52-week period.

This approval is notable because it offers a much-needed therapeutic option for patients with eosinophilic COPD, a form of the disease associated with elevated levels of blood eosinophils (≥300 cells/μL). These patients tend to experience more frequent exacerbations and often face a more severe disease course, even when treated with optimal inhaled therapies. Dupixent’s ability to reduce exacerbations and improve lung function represents a significant advancement in addressing the unmet needs of this patient group, who often suffer from a diminished quality of life due to breathing difficulties.

This approval presents a new strategy for managing eosinophilic COPD, particularly in cases where symptoms remain uncontrolled despite the best available treatment options. Building on its success in managing other inflammatory conditions, such as asthma and atopic dermatitis, Dupixent now provides an additional option for more effectively managing this difficult-to-treat form of COPD.