FDA Approves Nucala for COPD Patients with High Eosinophil Levels

The U.S. Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on treatment for adults with chronic obstructive pulmonary disease (COPD) who continue to have flare-ups despite using triple inhaled therapy. Nucala is the first biologic drug specifically approved for COPD patients with an “eosinophilic phenotype”—a group defined by having high levels of eosinophils, a type of white blood cell linked to inflammation.

About 70% of COPD patients in the U.S. who still suffer from symptoms despite treatment have a blood eosinophil count of 150 cells/μL or higher. Nucala, given as a monthly injection, works by targeting interleukin-5 (IL-5), a protein involved in inflammation. By reducing eosinophils, Nucala helps lower the risk of COPD flare-ups, including those that lead to hospital stays or emergency room visits.

The approval is based on strong results from two major clinical trials, MATINEE and METREX. In these studies, Nucala significantly reduced the number of moderate to severe flare-ups compared to a placebo. In one trial, it also lowered the rate of hospital visits, although this result was not statistically significant.

JoinAStudy.ca would like to congratulate Principal Investigator Dr Syed Anees, whose efforts were crucial in gathering the data necessary to arrive at these conclusions. The study participants and coordinator team at his research site also deserve acknowledgment and thanks for providing their valuable time and effort.

COPD is a progressive lung disease that affects over 390 million people globally and is the third leading cause of death. Symptoms include breathlessness, coughing, and mucus production. While inhaled therapies help many, a large portion of patients still experience serious flare-ups. Nucala offers a new option for these individuals.

GSK, the maker of Nucala, is also pursuing approval for this use in other countries.

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