Oct. 2, 2024 — The FDA has approved Regeneron and Sanofi’s drug Dupixent for patients with COPD (chronic obstructive pulmonary disease). Marking the sixth indication for the drug, the approval provides a new option for the 300,000 U.S. adults with inadequately controlled COPD and eosinophilic COPD (characterized by airway inflammation and a higher risk of flare-ups and hospitalizations). With the new use, Dupixent becomes the first biologic treatment for COPD in the U.S.
COPD is a long-term lung disease that makes breathing difficult and gets worse over time. It accounts for most deaths from chronic lower respiratory diseases, the sixth leading cause of death in the U.S. Common symptoms include a persistent cough, thick mucus in the lungs, and shortness of breath.
“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,” said Jean Wright, MD, chief executive officer at the COPD Foundation, in statement from Sanofi. “These patients often struggle with everyday activities many people take for granted such as taking a walk or running errands outside the home. We welcome the approval of this new therapeutic option to offer patients a new way to help gain better control of their disease.”
First approved in 2017, Dupixent is available as an injection in a prefilled pen. It will be used as an add-on maintenance treatment for adults whose COPD is not well controlled with inhalers. The drug (generic name dupilumab) is a monoclonal antibody, a type of treatment that recruits your body’s immune system to fight disease. It works by blocking the interleukin-4 and interleukin-13 receptors, which are major contributors to COPD-related changes in the lungs.
Dupixent’s list of indications already include asthma, eczema, chronic sinus inflammation with nasal polyps, eosinophilic food pipe inflammation, and prurigo nodularis (hard, itchy bumps on the skin).
The approval for COPD was based on two phase III clinical trials. The studies involved current or former smokers ages 40 to 85 with poorly controlled COPD. During the 52-week treatment period, Dupixent led to fewer flare-ups, better lung function and quality of life, and reduced respiratory symptoms compared with a placebo.
The most common side effects are injection-site reactions, viral infections, headaches, toothaches, sore throat, stuffy nose, back and joint pain, diarrhea, urinary tract infections, and high white blood cell count (eosinophilia), according to Regeneron and Sanofi.
