> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Dupixent Gains OK for Prurigo Nodularis
- URL: https://www.fdaweb.com/dupixent-gains-ok-for-prurigo-nodularis/
- Published: 2022-09-29T12:00:00.000Z
- Updated: 2026-09-14T18:01:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152856

FDA has approved Regeneron Pharmaceuticals’ Dupixent (dupilumab) for treating adult patients with prurigo nodularis, a chronic, debilitating skin disease with underlying Type 2 inflammation. Approval was based on data from two Phase 3 trials, [PRIME](https://c212.net/c/link/?t=0&l=en&o=3662470-1&h=521640014&u=https%3A%2F%2Finvestor.regeneron.com%2Fnews-releases%2Fnews-release-details%2Fdupixentr-dupilumab-late-breaking-phase-3-data-eadv-2022&a=PRIME&ref=fdaweb.com) and [PRIME2](https://c212.net/c/link/?t=0&l=en&o=3662470-1&h=3883528935&u=https%3A%2F%2Fnewsroom.regeneron.com%2Fnews-releases%2Fnews-release-details%2Flate-breaking-phase-3-data-aad-2022-show-dupixentr-dupilumab&a=PRIME2&ref=fdaweb.com), that assessed the proportion of subjects with clinically meaningful reduction in itch, clearing of skin, or both. Data showed that about three times as many Dupixent patients (60% and 58%) experienced a clinically meaningful reduction in itch from baseline at 24 weeks, compared to 18% and 20% for placebo, according to the company. Previously, Dupixent was approved for treating atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis.