Europe Approves Regeneron-Sanofi's Dupixent For Expanded Use In Eosinophilic Esophagitis

  • The European Commission approved Regeneron Pharmaceuticals Inc REGN and Sanofi SA's SNY Dupixent (dupilumab) for expanded use in eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older.
  • The approval covers patients inadequately controlled by, intolerant to, or not candidates for conventional medicinal therapy. 
  • EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
  • "This latest approval establishes Dupixent as the only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union," said George D. Yancopoulos, President and Chief Scientific Officer at Regeneron.
  • The decision is supported by 52-week data from a Phase 3 trial consisting of three parts (Part A, B, and C). 
  • Part A and Part B investigated Dupixent 300 mg weekly (Part A n=42; Part B n=80) compared to placebo (Part A n=39; Part B n=79) for 24 weeks. 
  • Part C (n=188) observed patients who had continued or switched to Dupixent from Parts A and B for an additional 28 weeks.
  • Dupixent patients in Parts A and B, respectively, experienced:
  • An approximately ten times higher rate of histological disease remission (60% and 59%), a co-primary endpoint, compared to placebo (5% and 6%).
  • A 69% and 64% reduction in disease symptoms compared to 32% and 41% with placebo. On disease symptoms, Dupixent patients experienced a 21.9- and 23.8-point clinically meaningful improvement compared to a 9.6- and 13.9-point improvement for placebo, a co-primary endpoint. 
  • Swallowing improvement was observed as early as four weeks.
  • Price Action: REGN shares closed at $742.83 on Friday. SNY shares are up 0.95% at $48.95 during the premarket session on the last check Monday.
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