FDA Approves First-Ever Biologic Medicine for COPD: Daily Dose

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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On September 27, 2024, we reported on the US Food and Drug Administration (FDA) approval of dupilumab (Dupixent) as add-on maintenance therapy for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and evidence of an eosinophilic phenotype.

The approval

With the approval, dupilumab becomes the first biologic agent approved in the US to treat the chronic lung disease and the first new treatment approach for COPD in more than a decade.

Clinical trials leading to the approval demonstrated that adults with COPD had significant reductions in annualized disease exacerbations and experienced improvements in both lung function and health-related quality of life. The fully human monoclonal antibody inhibits both interleukin-4 and -13 (IL-4, IL-13), a mechanism of action demonstrated across the dupilumab development program to decrease T2 inflammation in patients with atopic or allergic diseases. Identifying the central role of IL-4 and IL 13 in the type 2 inflammatory cascade led to the pivotal studies of inhibiting both as a means of reducing COPD exacerbations in individuals with a blood eosinophil level of 300 or more cells per mL.

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