Highlights 

  • Dupixent (dupilumab) receives EU approval for moderate-to-severe chronic spontaneous urticaria (CSU). 
  • Phase 3 LIBERTY-CUPID trials show notable reductions in itch and hives at 24 weeks. 
  • Approximately 270,000 people in the EU remain symptomatic despite antihistamine treatment. 
  • Dupixent becomes the first targeted CSU medicine approved in the EU in more than 10 years. 
  • Regeneron and Sanofi now have seven approved Dupixent indications in the EU. 

Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) announced that the European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who do not respond adequately to histamine-1 antihistamines and are naïve to anti-IgE therapy. This milestone marks the first targeted medicine approval for CSU in the European Union in more than a decade. 

The chronic condition affects more than 270,000 individuals across the EU who continue to experience debilitating episodes of itch and hives despite standard-of-care therapy. Dupixent, which inhibits IL-4 and IL-13—central drivers of type 2 inflammation—is now approved for seven inflammatory diseases in the EU. 

Tonya Winders, President and CEO of the Global Allergy & Airways Patient Platform, highlighted the impact of the approval, noting that the unpredictable and distressing nature of CSU severely affects quality of life and that Dupixent may offer meaningful symptom improvement.

Clinical Trial Data from LIBERTY-CUPID Program

The approval is supported by results from the Phase 3 LIBERTY-CUPID trials—Studies A, B and C—which evaluated Dupixent as an add-on therapy to standard antihistamines. Studies A and C, conducted in patients aged 12 years and older who were symptomatic despite antihistamines and naïve to anti-IgE therapy, demonstrated significant reductions in urticaria activity at 24 weeks compared with placebo. 

These studies assessed weekly urticaria activity score (UAS7), itch severity score (ISS7), and hive severity score (HSS7). Dupixent-treated patients showed meaningful improvements across all measures, including a higher proportion achieving well-controlled disease or complete response at week 24. 

Study B provided additional safety data and included patients who were inadequate responders or intolerant to anti-IgE therapy. Across all three trials, safety findings were consistent with Dupixent’s established profile. Common adverse events include injection site reactions, conjunctivitis, arthralgia, oral herpes, and eosinophilia. Additional local injection site reactions were observed in the CSU population. 

Broader Global Impact and Company Background

Beyond the EU, Dupixent is also approved for CSU in select countries, including the United States and Japan. The medicine continues to expand its global footprint as a targeted option for individuals whose symptoms are uncontrolled by existing therapies. 

Regeneron, a biotechnology company known for its physician-scientist leadership and proprietary VelociSuite technologies, continues to advance therapies across multiple disease areas. Sanofi, an innovation-driven biopharmaceutical company powered by AI and deep immunology expertise, partners with Regeneron to deliver Dupixent globally. 

Conclusion 

The latest EU approval of Dupixent marks a significant development for patients who lack effective alternatives for chronic spontaneous urticaria. With demonstrated improvements in itch, hives and disease control, the therapy offers a new pathway for those unresponsive to antihistamines. The decision reinforces Dupixent’s expanding role in addressing chronic inflammatory diseases and strengthens the longstanding collaboration between Regeneron and Sanofi. 

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