The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab for the treatment of adults with prurigo nodularis. The target action date for the FDA’s decision is September 30, 2022.
The sBLA is supported by data from the randomized, double-blind, placebo-controlled, parallel-group phase 3 PRIME2 (ClinicalTrials.gov identifier: NCT04202679) and PRIME (ClinicalTrials.gov identifier: NCT04183335) trials that assessed the efficacy and safety of dupilumab in patients 18 years of age and older with prurigo nodularis. Patients were randomly assigned to receive dupilumab or placebo every 2 weeks with or without topical treatments (low- or medium-dose topical corticosteroids or topical calcineurin inhibitors were continued if patients were using these at randomization).
The primary endpoint was the proportion of patients with improvement (reduction) in the worst-itch numeric rating scale (WI-NRS) by at least 4 points. The key secondary endpoint was the proportion of patients with Investigator’s Global Assessment score of clear ‘0’ or almost clear ‘1’ skin.
Results from PRIME2 showed that 37% of patients treated with dupilumab achieved a clinically meaningful reduction in itch at week 12 compared with 22% of those who received placebo (P =.0216). Moreover, 58% of dupilumab-treated patients had a clinically meaningful reduction in itch at week 24 vs 20% of the placebo group (P<.0001). A significantly greater proportion of patients in the dupilumab arm also achieved clear or almost clear skin at week 24 compared with the placebo arm (45% vs 16%; P <.0001).
Findings from the PRIME study showed that 60% of patients treated with dupilumab had a clinically meaningful reduction in itch at week 24 compared with 18% of those who received placebo (P <.0001). Moreover, 48% of patients in the dupilumab arm achieved clear or almost clear skin vs 18% of the placebo arm (P =.0004). Significantly greater improvements in measures of health-related quality of life, skin pain and symptoms of anxiety and depression were also observed with dupilumab.
Dupilumab is currently marketed under the brand name Dupixent® and is approved to treat moderate to severe asthma, moderate to severe atopic dermatitis, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis.
- FDA accepts Dupixent® (dupilumab) for Priority Review in adults with prurigo nodularis. News release. Regeneron Pharmaceuticals, Inc. Accessed May 31, 2022. https://www.prnewswire.com/news-releases/fda-accepts-dupixent-dupilumab-for-priority-review-in-adults-with-prurigo-nodularis-301557500.html
- Late-breaking phase 3 data at AAD 2022 show Dupixent® (dupilumab) significantly improved signs and symptoms of prurigo nodularis. News release. Regeneron Pharmaceuticals, Inc. March 26, 2022. Accessed May 31, 2022. https://investor.regeneron.com/news-releases/news-release-details/late-breaking-phase-3-data-aad-2022-show-dupixentr-dupilumab
This article originally appeared on MPR