Dupixent (Dupilumab) Receives FDA Approval for Pulmonary Disease COPD
The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injections as adjunctive therapy for some adults with uncontrolled chronic obstructive pulmonary disease (COPD).
“People living with uncontrolled COPD have long been waiting for new medications to help manage the daily suffering they experience from wheezing, coughing, shortness of breath, fatigue, and unexpected hospitalization,” Jean Wright, MD, executive director of the COPD Foundation, said in a statement from the drugmaker.
“These patients often struggle with daily activities that many people take for granted, such as walking or running outside the house,” Dr. Wright said in the statement. “We welcome the approval of this new treatment option to give patients a new way to help better manage their disease.”
When Inhaled Medicines Don’t Work for COPD
People with COPD suffer from conditions that block the flow of air in the lungs and make it difficult to breathe. Many people have emphysema, which occurs when the air sacs in the lungs called alveoli don’t work properly, or chronic bronchitis – which occurs when inflammation in the airways causes mucus to build up in the lungs.
Many patients with COPD take multiple medications to manage 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 them. inflammation, or people who had recently used two bronchodilators because steroids were not. good choice for them.
“We have good medications for COPD and many patients respond and their breathing improves and their ability to do things improves,” says Nick Hanania, MD, professor, director of the center of aeromedical research at Baylor College of Medicine, Houston. , and a research assistant in medicine.
Dr. “However, about 40 to 50 percent of patients who use these inhalers go on to have an overdose,” Hanania says.
Dupixent reduced moderate to severe COPD in clinical trials
In two recent clinical trials, current and former smokers with COPD had significantly fewer symptoms when Dupixent was added to a two- or three-drug regimen of smoking cessation. of COPD. All patients also had lung inflammation confirmed by high levels of blood eosinophils. Both trials assigned patients to take either Dupixent or a placebo along with their usual form of treatment for 52 weeks.
These findings suggest that Dupixent may be a good adjunctive therapy for people with high eosinophil levels that suggest inflammation in their lungs and who do not get adequate symptom relief from COPD inhalers, says Hanania.
“In clinical trials, we have shown that this drug in this area reduces exacerbations and improves lung function and symptoms better than existing treatments,” says Hanania.
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