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Press release: Dupixent® (dupilumab) first to be approved by the FDA – Press Release

Double® (Dupilumab) first approved by the FDA and only Treatment indicated for prurigo node

  • Dupixent significantly reduced itching and skin lesions compared to placebo in the direct phase 3 program, which consisted of two pivotal studies
  • Approximately 75,000 US adults living with nodular pruritus are in dire need of new treatment options
  • The approval marks the second dermatological indication for Dupixent and the fifth indication overall in the United States

Paris and Tarrytown, New York September 282022. The US 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 drug specifically indicated for the treatment of prurigo nodularis in the United States. The FDA evaluated the Dupixent application for prurigo nodularis as part of priority review granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious diseases.

Naimish Patel, MD
Head of Global Development, Immunology and Inflammation, Sanofi
“To date, there have been limited treatment options to manage the unrelenting itching and associated skin burning and stinging sensations which can negatively impact the lives of patients struggling with prurigo node. Dupixent has the potential to do so transform the standard of care for prurigo node patients by alleviating the main characteristics of the disease, such as B. reducing itching and achieving clearer skin. With dupixent now approved in two illnesss in dermatology where type 2 inflammation is a key driverwe look forward to further investigating the potential of inhibiting IL-4 and IL-13 in other chronic skin diseases.

George D YancopoulosMD, Ph.D.
President and Chief Scientific Officer, Regeneron

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