Regeneron-Sanofi's Dupixent Wins European Approval For Prurigo Nodularis

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