The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injections as an adjunctive therapy for certain adults with poorly controlled chronic obstructive pulmonary disease (COPD).
“People living with inadequately controlled COPD have long waited for new medicines to help manage the daily suffering they experience from shortness of breath, cough, wheezing, fatigue and unpredictable hospital admissions,” said Jean Wright, MD, CEO COPD Foundation. statement of the drug manufacturer.
“These patients often struggle with everyday activities that many people take for granted, such as going for a walk or running errands outside the home,” said Dr. Wright in the statement. “We welcome the approval of this new treatment to offer patients a new way to help better control their disease.”
When inhaled medications aren’t doing enough for COPD
People with COPD suffer from diseases 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 work properly, or chronic bronchitis – which happens when inflammation of the airways causes mucus to build up in the lungs.
Many COPD patients take a combination of several medications to control symptoms such as chronic cough, chest tightness, 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 were only using two bronchodilators because steroids were not a good choice for them.
“We have good drugs for COPD, and most patients respond and their shortness of breath improves and their ability to do things improves,” says Nick Hanania, MD, professor, director of the Airway Clinical Research Center at Baylor College of Medicine in Houston, and co-author of studies on the drug.
“However, about 40 to 50 percent of patients on these inhalers continue to experience exacerbations,” says Dr. Hananiah.
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 exacerbations when Dupixent was added to a regimen of two or three inhaled COPD medications. All patients also had pneumonia confirmed by elevated blood eosinophils. In both studies, patients were randomly assigned to receive Dupixent or placebo along with their usual regimen for 52 weeks.
These findings suggest that Dupixent may be a good adjunctive therapy for people who have high eosinophil levels indicative of lung inflammation and who do not get adequate relief of their COPD symptoms from inhalers, Hanania says.
“In clinical trials, we demonstrated that this drug in this subgroup reduces progression and improves lung function and improves symptoms on top of current treatment,” says Hanania.
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