Key Takeaways
- Dupixent® (dupilumab) becomes the first-ever biologic medicine approved in the U.S. for adults with chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.
- Phase 3 trials demonstrated Dupixent’s significant reduction in exacerbations, improved lung function, and enhanced quality of life for patients with COPD.
- Dupixent continues to lead in new-to-brand prescriptions across its FDA-approved indications and is the top prescribed biologic by pulmonologists in the U.S.
Regeneron Pharmaceuticals, Inc. and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype and have not adequately responded to current treatments. Dupixent® is the first biologic medicine approved in the U.S. for this patient population, marking a significant advancement in the management of COPD.
This approval is based on two landmark Phase 3 trials, BOREAS and NOTUS, which demonstrated Dupixent’s remarkable efficacy compared to placebo, reducing exacerbations and improving lung function and quality of life for patients struggling with the daily challenges of COPD.
Jean Wright, M.D., CEO of the COPD Foundation, emphasized the impact this approval will have, stating, “For many patients, COPD significantly limits daily activities. This approval provides a new therapeutic option that can help patients regain some control over their condition.”
Significant Results from Landmark Phase 3 Trials
The BOREAS and NOTUS Phase 3 trials were conducted on patients with COPD and elevated levels of blood eosinophils, a marker linked to more severe disease. Both trials evaluated Dupixent in patients who were already on maximal standard-of-care inhaled therapies. Dupixent® significantly reduced the annualized rate of moderate or severe exacerbations by 30% and 34% in the two trials, respectively. Additionally, Dupixent demonstrated improved lung function, with numerical increases in FEV1 (a measure of lung capacity) of 74 mL and 68 mL, which were sustained over 52 weeks.
The trials also highlighted quality-of-life improvements, with more than half of Dupixent-treated patients experiencing a significant positive change in their day-to-day well-being, as assessed by the St. George’s Respiratory Questionnaire.
A New Era for COPD Treatment
According to George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, the approval of Dupixent represents a major leap forward for patients suffering from the debilitating effects of COPD. “Dupixent has already shown its ability to transform care in several type 2 inflammatory diseases. This approval brings new hope to COPD patients who have struggled to manage their disease with standard treatments.”
Approximately 300,000 people in the U.S. have inadequately controlled COPD with an eosinophilic phenotype, making Dupixent’s approval a critical milestone for this underserved population. Paul Hudson, CEO of Sanofi, stated, “Dupixent is revolutionizing treatment for multiple diseases driven by type 2 inflammation, and now we can offer new options for patients living with COPD.”
The safety results from the BOREAS and NOTUS trials were consistent with Dupixent’s established safety profile. The most commonly reported adverse events were viral infections, headaches, back pain, and local injection site reactions. Dupixent® was well tolerated overall, with a low incidence of severe side effects.
Global Regulatory Expansion and Future Research
Following its approval in the U.S., Dupixent® has been submitted for regulatory review in several other regions, including the EU, Japan, and Canada. It has also recently been approved in Europe as an add-on treatment for COPD. Dupixent® continues to show promise in other indications, with ongoing clinical trials exploring its potential across multiple diseases driven by type 2 inflammation. Beyond Dupixent, Regeneron and Sanofi are committed to further exploring the treatment of COPD through other innovative approaches, including the investigation of itepekimab, a monoclonal antibody targeting interleukin-33 (IL-33).
Chronic obstructive pulmonary disease (COPD) is a progressive lung condition that makes it difficult to breathe and affects millions of people worldwide. The disease is the fourth leading cause of death globally, with symptoms including chronic cough, excessive mucus, and shortness of breath, which severely impact daily activities. Patients often require frequent hospitalization due to exacerbations, which further compromise their quality of life. With Dupixent® now approved for COPD, it opens the door to better management of this life-limiting condition, improving patient outcomes and reducing exacerbations. The approval of this first-in-class biologic for COPD patients marks a new chapter in respiratory care.
Resource: Regeneron, September 27, 2024
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