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May 25, 2025 — In a significant development for patients with chronic obstructive pulmonary disease (COPD), the U.S. Food and Drug Administration (FDA) has approved the use of Nucala (mepolizumab) as an add-on treatment for adults with a specific, hard-to-treat form of the disease known as eosinophilic COPD. This marks the fifth FDA approval for Nucala and only the second time a biologic therapy has been cleared for COPD, following the approval of Dupixent in September 2024.
What Is Eosinophilic COPD?
COPD is a chronic, progressive lung disease that affects more than 390 million people globally and is the third leading cause of death worldwide. Eosinophilic COPD is a subtype characterized by higher levels of eosinophils—a type of white blood cell that contributes to airway inflammation. Patients with this form of COPD often experience more frequent flare-ups, leading to hospitalizations and permanent lung damage.
Even moderate elevations in blood eosinophil counts (as low as 150 cells/µL) can increase the risk of exacerbations. According to experts, about 70% of COPD patients continue to have flare-ups despite regular use of inhalers, especially when eosinophil levels are elevated.
How Does Nucala Work?
Nucala is a monoclonal antibody that targets interleukin-5 (IL-5), a protein that plays a key role in the inflammation associated with eosinophilic COPD. By blocking IL-5, Nucala helps reduce the number of eosinophils and, in turn, inflammation in the lungs. The drug is administered via injection by a healthcare provider.
Clinical Trial Results
The FDA’s decision was based on two large clinical trials involving more than 1,600 patients whose COPD was not well controlled with standard inhaler therapy. The studies found that patients receiving Nucala injections every four weeks experienced 18% to 21% fewer moderate to severe flare-ups compared to those given a placebo.
“COPD isn’t just a disease, it’s a relentless cycle,” said Dr. Jean Wright, CEO of the COPD Foundation, in a statement. “For individuals living with COPD, managing exacerbations is an ongoing challenge, even with inhaled maintenance therapy. Biologics like mepolizumab are providing renewed optimism for those affected by COPD.”
Safety and Side Effects
Nucala is already approved in the United States for treating four other conditions related to IL-5. The most common side effects reported in clinical trials included back pain, diarrhea, and cough.
Looking Ahead
The approval of Nucala offers new hope for adults with eosinophilic COPD who continue to struggle with flare-ups despite standard therapies. As more biologic treatments become available, experts are optimistic about improving the quality of life for millions living with this chronic lung disease.
Disclaimer:
This article is for informational purposes only and should not be considered medical advice. Please consult a healthcare professional for personalized recommendations and before starting any new treatment. The information is based on publicly available data as of May 25, 2025, and may be subject to change as new research emerges.
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