Sanofi and Regeneron’s Dupixent (dupilumab) Receive the US FDA’s Approval as 1L Treatment for Prurigo Nodularis
Shots:
- The US FDA has approved Dupixent for PN. The approval was based on the 2 P-III (PRIME) & (PRIME2) study evaluating Dupixent vs PBO in 311 adults with uncontrolled PN
- In both trials, 60% & 58% vs 18% & 20% of patients experienced a clinical reduction in itch from baseline @24wks.; 44% & 37% vs 16% & 22% @12wks., patients achieved clear or almost clear skin (48% & 45% vs 18% & 16%) @24wks.
- Additionally, 39% & 32% vs 9% & 9% experienced both clinical reductions in itch & clear or almost clear skin @24wks. & the safety results were consistent with the known safety profile in its approved dermatology indication. The regulatory filing is under EMA’s review for PN & submissions to regulatory authorities in additional countries are also planned in 2022
Ref: Sanofi | Image: Sanofi
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