The U.S. Food and Drug Administration has approved Nucala for adults with chronic obstructive pulmonary disease (COPD), marking a significant development for patients with hard-to-treat forms of the condition. This decision makes Nucala only the second biologic therapy approved for COPD, following the earlier approval of Dupixent.
The new approval allows Nucala to be used as an add-on treatment for eosinophilic COPD a subtype characterized by higher levels of eosinophils, a type of white blood cell involved in inflammation. This condition tends to cause frequent flare-ups and hospitalizations, even among patients who are already on standard inhaled maintenance therapies.
COPD is a progressive respiratory disease that causes chronic inflammation in the lungs, narrowing the airways and making it increasingly difficult to breathe. It affects more than 390 million people worldwide and is the third leading cause of death globally. Eosinophilic COPD represents a particularly challenging subtype of the disease. Even a moderate eosinophil level 150 cells per microliter of blood is associated with an increased risk of exacerbations. About 70% of COPD patients experience recurrent flare-ups despite the use of inhalers, especially when eosinophil counts exceed this threshold. These exacerbations not only impact quality of life but can also result in long-term lung damage.
Nucala, a monoclonal antibody with the generic name mepolizumab, is designed to work alongside existing inhaled therapies. It targets interleukin-5 (IL-5), a protein that plays a key role in the inflammatory process associated with eosinophilic COPD. By neutralizing IL-5, Nucala helps reduce the level of eosinophils in the blood, thereby lowering inflammation and the frequency of flare-ups. The drug is administered via injection by a healthcare provider once every four weeks.
This recent FDA approval was supported by data from two pivotal clinical trials involving more than 1,600 patients. In these studies, patients who received Nucala had significantly fewer episodes of moderate to severe exacerbations compared to those who received a placebo. Specifically, Nucala reduced the frequency of flare-ups by 18% to 21%, a meaningful improvement for patients with limited treatment options.
First introduced in 2015, Nucala has already been approved for the treatment of four other IL-5-related conditions, including severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis. Its approval for eosinophilic COPD represents the fifth indication for the drug. The most commonly reported side effects include back pain, diarrhea, and cough.
The availability of Nucala offers new hope to patients living with eosinophilic COPD, who often face a relentless cycle of symptom management and hospital visits. The use of biologic therapies such as Nucala signals a broader shift in the treatment landscape for chronic lung diseases, providing targeted interventions that go beyond traditional inhaled medications. For many, this advancement could represent a turning point in managing a condition that has long been resistant to standard therapies.
