Dupixent Expands Marketing Authorization in EU for Eosinophilic Esophagitis Treatment

Strategic Insights -

Eosinophilic esophagitis (EoE) is a chronic, progressive inflammatory disease that causes damage to the esophagus and impairs its ability to function. The European Commission has granted Sanofi's Dupixent (dupilumab) expanded marketing authorization to treat this condition in adults and adolescents aged 12 years and older in the European Union.

According to Naimish Patel, M.D., Head of Global Development, Immunology and Inflammation at Sanofi, "The impact of EoE on a patient's daily life cannot be overstated." Patients with EoE may experience painful and distressing experiences while eating, which can lead to difficulty swallowing, food impaction, and other complications. With Dupixent, adults and adolescents with EoE in the EU now have a targeted treatment option that has been shown to reduce esophageal inflammation and damage, improve swallowing ability, and alleviate health-related quality of life.

Key Takeaways:

  • Dupixent has been granted marketing authorization for the treatment of eosinophilic esophagitis (EoE) in adults and adolescents aged 12 years and older in the European Union.
  • The expanded authorization is based on data from a 52-week Phase 3 trial, which demonstrated significant improvements in patients with EoE treated with Dupixent, including:

+ 69% and 64% reduction in disease symptoms compared to 32% and 41% with placebo.

+ 10 times higher rate of histological disease remission (60% and 59%) compared to placebo (5% and 6%).

+ Clinically meaningful improvement in swallowing-related pain and health-related quality of life.

  • Dupixent has been shown to be a safe and effective treatment option for EoE, with a side effect profile consistent with previously approved indications.
  • Sanofi and Regeneron are continuing to investigate the potential of Dupixent in additional diseases driven by type 2 inflammation.

Statistics:

  • Approximately 50,000 adults and adolescents in the EU live with severe uncontrolled EoE.
  • Dupixent has been administered to over 500,000 patients globally.
  • The Dupilumab development program has been studied across over 60 clinical trials involving over 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

Sources:

  • Sanofi
  • Regeneron
  • European Commission
  • Contify.com