The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injections as an add-on therapy for certain adults with poorly controlled chronic obstructive pulmonary disease (COPD).
“People living with inadequately controlled COPD have long awaited new medicines to help manage the daily suffering they experience from breathlessness, coughing, wheezing, exhaustion, and unpredictable hospitalization,” Jean Wright, MD, the chief executive officer at the COPD Foundation, said in the drugmaker’s statement.
“These patients often struggle with everyday activities many people take for granted, such as taking a walk or running errands outside the home,” Dr. Wright said in the statement. “We welcome the approval of this new therapeutic option to offer patients a new way to help gain better control of their disease.”
When Inhaled Medications Aren’t Doing Enough for COPD
People with COPD suffer from conditions that restrict the flow of air in the lungs and make it difficult to breathe. Most people have either emphysema, which happens when air sacs in the lungs called alveoli don’t function properly, or chronic bronchitis — which happens when inflammation in the airways causes mucus to accumulate in the lungs.
Many patients with COPD take a combination of several medications to manage symptoms like chronic cough, tightness in the chest, wheezing, shortness of breath, and fatigue. In clinical trials reviewed by the FDA as part of the approval process, Dupixent was tested in people who were already taking two inhaled bronchodilators to open the airways and an inhaled steroid to reduce inflammation, or people who just used two bronchodilators because steroids weren’t a good option for them.
“We have good medications for COPD and most patients respond and their shortness of breath improves and their ability to do things improve,” says Nick Hanania, MD, a professor, the director of the airways clinical research center at Baylor College of Medicine in Houston, and a coauthor of research on the medication.
“However, about 40 to 50 percent of patients on these inhalers continue to experience exacerbation,” Dr. Hanania says.
Dupixent Reduced Moderate to Severe COPD Exacerbations in Clinical Trials
In two late-stage clinical trials, current and former smokers with COPD had significantly fewer symptom exacerbations when Dupixent was added to a treatment regimen of two or three inhaled COPD medicines. All the patients also had lung inflammation confirmed by elevated blood levels of eosinophils. Both trials randomly assigned patients to take Dupixent or a placebo along with their regular treatment regimen for 52 weeks.
These findings suggest that Dupixent may be a good add-on therapy for people who have high eosinophil levels that suggest inflammation in their lungs and who don’t get enough symptom relief from COPD inhalers, says Hanania.
“In clinical trials, we demonstrated that this drug in this subpopulation decreases exacerbations and improves lung function and improves symptoms on top of existing therapies,” Hanania says.
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