October 2, 2024 – The FDA has approved Regeneron and Sanofi's drug Dupixent for patients with COPD (chronic obstructive pulmonary disease). The approval marks the sixth indication for the drug and provides a recent option for 300,000 U.S. adults with inadequately controlled COPD and eosinophilic COPD (characterised by airway inflammation and the next risk of flare-ups and hospitalization). The recent application makes Dupixent the primary biologic drug to treat COPD within the United States
COPD is a long-term lung disease that makes respiratory difficult and gets worse over time. It explains most deaths from chronic lower respiratory diseases, the sixth leading reason for death within the United States. Common symptoms include persistent cough, thick mucus within the lungs, and shortness of breath.
“People living with poorly controlled COPD have been waiting a long time for new medications to help manage the daily suffering they endure from shortness of breath, coughing, wheezing, fatigue and unpredictable hospitalizations,” said Dr. Jean Wright, executive director of the COPD Foundation opinion from Sanofi. “These patients often have problems with everyday activities that many people take for granted, such as going for a walk or running errands outside the home. We welcome the approval of this new treatment option to offer patients a new opportunity to gain better control of their disease.”
Dupixent was first approved in 2017 and is accessible as an injection in a pre-filled pen. It is used as adjunctive maintenance therapy for adults whose COPD just isn't well controlled with inhalers. The drug (generic name dupilumab) is a monoclonal antibody, a style of treatment that stimulates your body's immune system to fight disease. It works by blocking the interleukin-4 and interleukin-13 receptors, which contribute significantly to COPD-related changes within the lungs.
Dupixent's indication list already includes asthma, eczema, chronic sinusitis with nasal polyps, eosinophilic esophagitis and prurigo nodularis (hard, itchy bumps on the skin).
Approval for COPD was based on two Phase III clinical trials. The studies involved current or former smokers aged 40 to 85 years with poorly controlled COPD. During the 52-week treatment period, Dupixent resulted in fewer disease flare-ups, higher lung function and quality of life, and a discount in respiratory symptoms in comparison with placebo.
The most typical negative effects, in accordance with Regeneron and Sanofi, are injection site reactions, viral infections, headache, toothache, sore throat, nasal congestion, back and joint pain, diarrhea, urinary tract infections, and high white blood cell counts (eosinophilia). .