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Sanofi and Regeneron’s Dupixent (dupilumab) Receive the US FDA’s Approval as 1L Treatment for Prurigo Nodularis

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Sanofi and Regeneron’s Dupixent (dupilumab) Receive the US FDA’s Approval as 1L Treatment for Prurigo Nodularis

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  • 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 

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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