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.