Regeneron-Sanofi's Dupixent Wins European Approval For Prurigo Nodularis - Regeneron Pharmaceuticals (NASDAQ:REGN), Sanofi (NASDAQ:SNY)


  • The European Commission (EC) has expanded the marketing authorization of Regeneron Pharmaceuticals Inc REGN and Sanofi SA’s SNY Dupixent (dupilumab) for moderate-to-severe prurigo nodularis.
  • Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation. 
  • With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat prurigo nodularis in Europe and the U.S.
  • Related: UK Drug Regulator Warns Of Severe Eye Reactions Associated With Sanofi/Regeneron’s Dupixent.
  • The approval is based on data from two Phase 3 trials, PRIME and PRIME2, evaluating the efficacy and safety of Dupixent. In these trials, 44% and 37% of Dupixent patients experienced a clinically meaningful reduction in itch at 12 weeks, compared to 16% and 22% for placebo, respectively. 
  • The improvement further increased at 24 weeks, with approximately three times as many Dupixent patients (60% and 58%) experiencing a clinically meaningful reduction in itch from baseline, compared to placebo (18% and 20%).
  • In PRIME and PRIME2, more than twice as many Dupixent patients (48% and 45%) also achieved clear or almost clear skin at 24 weeks, compared to placebo (18% and 16%).
  • Price Action: REGN shares closed at $750.00 on Wednesday. SNY shares are down 0.25% at $47.83 during the premarket session on the last check Thursday.
  • Photo Via Company


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