The U.S. Food and Drug Administration (FDA) has granted approval for Dupixent (dupilumab) injections as an add-on therapy for adults struggling with poorly controlled chronic obstructive pulmonary disease (COPD). This decision marks a significant advancement in the treatment of COPD, particularly for patients who are still experiencing symptoms despite using inhaled medications.
Dupixent has been specifically approved for adults with COPD who have elevated levels of eosinophils—white blood cells that can cause inflammation in the lungs, exacerbating breathing difficulties. The drug, produced by Sanofi, serves as a maintenance therapy, allowing patients to continue their existing inhaled treatments while adding Dupixent to their regimen. According to Sanofi, Dupixent is the first biologic medication approved for the treatment of COPD, representing a new approach to managing this chronic condition.
Jean Wright, MD, CEO of the COPD Foundation, expressed optimism regarding the approval, stating that individuals with inadequately controlled COPD have long awaited effective medications to alleviate their daily struggles with symptoms like breathlessness, coughing, and fatigue. “These patients often struggle with everyday activities many people take for granted, such as taking a walk or running errands outside the home,” she noted, emphasizing the need for better management options for those living with this debilitating disease.
COPD encompasses a range of respiratory conditions that impede airflow, making breathing increasingly difficult. Most patients with COPD typically suffer from either emphysema, which affects the air sacs in the lungs, or chronic bronchitis, characterized by inflammation and mucus buildup in the airways. Many individuals with the disease rely on a combination of medications to alleviate symptoms such as chronic cough, chest tightness, and wheezing.
In its approval process, the FDA reviewed clinical trials involving participants who were already using two inhaled bronchodilators and, in some cases, inhaled steroids. Dr. Nick Hanania, a professor and director of the Airways Clinical Research Center at Baylor College of Medicine, highlighted that while existing medications can be effective for many patients, approximately 40% to 50% continue to experience exacerbations of their symptoms.
Clinical trials have shown that Dupixent significantly reduces moderate to severe exacerbations in COPD patients who have high eosinophil levels. In one pivotal trial, participants taking Dupixent experienced a 14% reduction in exacerbations over one year compared to a 30% increase in those receiving a placebo. Similarly, another trial indicated a 22% reduction in exacerbations among those on Dupixent, compared to a 10% increase in the placebo group. Importantly, the side effect profile of Dupixent was comparable to that of the placebo, with around 68% of patients experiencing side effects, which is consistent with findings from both trials.
These results suggest that Dupixent may provide a valuable option for patients who are not achieving adequate symptom relief from traditional inhalers, particularly those with significant lung inflammation indicated by elevated eosinophil levels. Dr. Hanania noted that the drug has been shown to decrease exacerbations, improve lung function, and enhance overall symptoms in this specific patient population.
As Dupixent becomes available to patients, it offers a new avenue of hope for those struggling with COPD, potentially improving their quality of life and allowing them to engage more fully in daily activities.
