The European Commission (EC) has expanded the marketing authorization of Regeneron Pharmaceuticals IncREGN and Sanofi SA’sSNY 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.
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.
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