Regeneron-Sanofi's Flagship Dupixent Becomes First FDA-Approved Treatment For Prurigo Nodularis

  • The FDA approved Regeneron Pharmaceuticals Inc REGN and Sanofi SA's SNY Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis. 
  • With this approval, Dupixent became the first and only medicine specifically indicated to treat prurigo nodularis in the U.S. 
  • Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation. 
  • The FDA evaluated the Dupixent application for prurigo nodularis under Priority Review.
  • Related: Regeneron-Sanofi Eczema Drug Shows Improvements In Itchy Inflammatory Skin Disease.
  • The FDA approval is based on data from two Phase 3 trials.
  • About three times as many Dupixent patients experienced a clinically meaningful reduction in itch compared to placebo at 24 weeks.
  • Compared to placebo, more than twice as many Dupixent patients achieved clear or almost clear skin at 24 weeks.
  • More than three times as many Dupixent patients experienced both a clinically meaningful reduction in itch and clear or almost clear skin compared to placebo patients at 24 weeks.
  • Price Action: REGN shares are trading lower by 0.90% at $699.07, and SNY stock is down 0.92% at $37.82 on the last check Thursday.
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