The European Commission has approved Dupixent (dupilumab) as the first targeted therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils.
Key points:
- Dupixent significantly reduced exacerbations, improved lung function, and enhanced health-related quality of life in COPD patients.
- This is the first new treatment approach for COPD in more than a decade, offering a new option for approximately 220,000 adults in the European Union.
- The approval is based on two landmark Phase 3 trials, BOREAS and NOTUS, which demonstrated significant improvements in patients with uncontrolled COPD.
Market estimate: The global COPD treatment market was valued at $20.4 billion in 2022 and is expected to reach $31.7 billion by 2030, according to Grand View Research.
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In a landmark decision, the European Commission has approved Dupixent (dupilumab) as the first-ever targeted therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.
This approval marks a significant milestone in COPD treatment, offering new hope to approximately 220,000 adults in the European Union who have been waiting for a novel treatment approach for over a decade.
Developed by Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi (NYSE: SNY), Dupixent has shown remarkable results in two Phase 3 clinical trials, BOREAS and NOTUS. The drug demonstrated a 30-34% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks, along with significant improvements in lung function and health-related quality of life.
Dr. George D. Yancopoulos, Board Co-Chair, President and Chief Scientific Officer at Regeneron, expressed pride in the drug’s potential to “redefine the treatment landscape” for COPD. He highlighted Dupixent’s “unprecedented improvements on exacerbations and lung function” as key factors in its approval.
The approval is particularly significant given the devastating nature of COPD, which is the fourth leading cause of death worldwide. Tonya Winders, President and CEO of the Global Allergy & Airways Patient Platform, emphasized the physical and mental toll of the disease on patients, stating that many feel “marginalized and isolated” due to its effects.
Dupixent’s mechanism of action targets the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, key drivers of type 2 inflammation in COPD. This targeted approach sets it apart from traditional COPD treatments and opens up new possibilities for patient care.
Paul Hudson, CEO of Sanofi, expressed enthusiasm about changing the treatment landscape for COPD patients, stating, “We can change the treatment landscape for the more than 200,000 patients throughout the EU living with uncontrolled COPD with raised blood eosinophils.”
The global COPD treatment market is expected to reach $31.7 billion by 2030, according to Grand View Research. This approval positions Dupixent to potentially capture a significant share of this growing market.
As the first regulatory authority in the world to approve Dupixent for COPD patients, the European Commission’s decision may pave the way for similar approvals in other regions. Additional submissions are currently under review with regulatory authorities in the U.S., China, and Japan.
For COPD patients who have long struggled with limited treatment options, the approval of Dupixent represents a new era of disease management.
