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Regeneron, Sanofi: FDA Approves Dupixent for Prurigo Nodularis

Sept. 28, 2022, 9:48 PM

Regeneron Pharmaceuticals and Sanofi announced that the U.S. FDA has approved dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis, according to a statement issued by the companies today.

  • FDA evaluated the dupixent application for prurigo nodularis under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions, the companies said
  • A regulatory filing for prurigo nodularis is under review by the European Medicines Agency, and submissions to regulatory authorities in additional countries are also planned in 2022

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