FDA Approves Dupixent as First Biologic for COPD

The US Food and Drug Administration (FDA) recently approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. This marks the first time a biologic medicine has been approved in the United States specifically for these patients.

Jean Wright, M.D., Chief Executive Officer at The COPD Foundation, expressed optimism about the approval, highlighting the longstanding need for new treatments to help patients manage symptoms like breathlessness, coughing, and wheezing. These symptoms severely impact daily activities such as walking or running errands, often leading to hospitalizations. Wright emphasized that this new therapeutic option could help patients achieve better control over their condition.

Paul Hudson, Chief Executive Officer at Sanofi, stated that Dupixent has already transformed treatment paradigms for several diseases driven by type 2 inflammation. He noted that over one million patients worldwide are being treated with Dupixent for various approved indications. This latest FDA approval further establishes Dupixent as the first and only approved biologic add-on treatment for inadequately controlled COPD, offering patients the potential for improved breathing and fewer exacerbations.

The FDA’s approval was based on data from two pivotal phase 3 studies, BOREAS and NOTUS, which assessed the efficacy and safety of Dupixent compared to a placebo. The studies involved adults on maximal standard-of-care inhaled therapy, nearly all of whom were on triple therapy, with inadequately controlled COPD and blood eosinophils ≥300 cells per μL. In these studies, patients treated with Dupixent experienced significant improvements in their condition compared to those on placebo.

The safety profile of Dupixent in these studies was consistent with its known safety in other approved indications. The most common adverse events observed in patients treated with Dupixent included viral infections, headaches, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infections, local administration reactions, rhinitis, eosinophilia, toothache, and gastritis. A less common adverse event, cholecystitis, was reported in 0.6% of patients on Dupixent compared to 0.1% on placebo.

George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President, and Chief Scientific Officer at Regeneron, noted that this new FDA approval offers hope to the many COPD patients who struggle with daily breathing challenges. He highlighted Dupixent’s track record as a first-in-class medicine for type 2 inflammatory diseases such as asthma and atopic dermatitis. Yancopoulos emphasized that this approval provides COPD patients with a novel treatment option that has demonstrated the ability to reduce exacerbations and improve quality of life in phase 3 studies.

The FDA’s evaluation of Dupixent was conducted under Priority Review, a designation for medicines that offer significant improvements in treating serious conditions. In July 2024, Sanofi and Regeneron announced that the European Medicines Agency also approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by elevated blood eosinophils. Submissions for regulatory approval are currently underway in other regions, including Japan.

COPD is a severe respiratory disease that leads to progressive lung function decline and is a leading cause of death worldwide. Symptoms include persistent cough, excessive mucus production, and shortness of breath, which can impair daily activities and contribute to sleep disturbances, anxiety, and depression. Despite being on triple inhaled therapy, about half of COPD patients continue to experience exacerbations.

The phase 3 study program for Dupixent included two large-scale studies, BOREAS and NOTUS, which enrolled 1,874 patients aged 40 to 85 years. These double-blind, placebo-controlled studies evaluated Dupixent’s efficacy and safety in adults with moderate-to-severe COPD and an eosinophilic phenotype. Over the 52-week treatment period, patients received Dupixent or placebo in addition to a maximal inhaled triple therapy. The studies focused on the annualized rate of acute COPD exacerbations and improvements in lung function and quality of life.

Sanofi and Regeneron continue their research efforts to transform COPD treatment by investigating the roles of various inflammatory pathways, including those targeted by Dupixent and other potential therapies such as itepekimab.