Press Release: Dupixent® (dupilumab) approved by FDA as the first and only treatment indicated for prurigo nodularis

Dupixent® (dupilumab) approved by FDA as the first and only treatment indicated for prurigo nodularis

  • Dupixent significantly reduced itch and skin lesions compared to placebo in direct-to-Phase 3 program consisting of two pivotal trials
  • About 75,000 adults in the U.S. living with prurigo nodularis are most in need of new treatment options
  • Approval represents the second dermatology indication for Dupixent and fifth disease indication overall in the U.S.

Paris and Tarrytown, N.Y. September 28, 2022. The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult patients with prurigo nodularis. With this approval, Dupixent becomes 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 and its impact on quality of life…



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