FDA accepts application for dupilumab to treat chronic spontaneous urticaria
The application indication is for adults and pediatric patients aged 12 years and older with CSU whose disease is not adequately controlled with H1 antihistamines.
FDA accept application for dupilumab to treat chronic spontaneous urticariaLatest revision | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.
The FDA has accepted the resubmitted supplemental Biologics License Application (sBLA) for dupilumab (Dupixent; Regeneron and Sanofi) for the treatment of chronic spontaneous urticaria (CSU) in adults and pediatric pateints aged 12 years and older. According to a press release from Regeneron, the IL-4 and IL-13 inhibitor for this CSU indication is designed to treat those whose disease is not adequately controlled with H1 antihistamine treatment.1
With the sBLA accepted, the federal agency has set a target action date of April 18, 2025 for potential approval. If approved, dupilumab would be the first targeted therapy for CSU in a decade, according to Regeneron and Sanofi.1
The resubmitted sBLA was supported by data from the LIBERTY-CUPID phase 3 clinical program that featured Study A, Study B, and Study C. This sBLA added results from Study C, which was carried out in patients with uncontrolled CSU who were on standard-of-care antihistamines. This study met primary and key secondary endpoints that confirmed results in Study A.1
In Study A and Study B—phase 3, randomized, placebo-controlled, double-blind trials, that compared dupilumab with placebo in symptomatic CSU patients despite H1-AH—the treatment met the primary and all key secondary outcomes.2,3
Study A featured omalizumab-naive patients (n = 138) aged 6 years or older. Study B featured omalizumab-intolerant/incomplete responders (n = 108) aged 12 years and older. The primary endpoint was change from baseline over 7 days in the Urticaria Activity Score (UAS7) or Itch Severity Score (ISS7) at week 24.2
In Study A, UAS7 and ISS7 improved with dupilumab compared to placebo (difference -8.5 [95% CI, -13.2 to -3.9; P = .0003] and -4.2 [95% CI, -6.6 to -1.8; P = .0005]), according to results published The Journal of Allergy and Clinical Immunology.2
In Study B (tested at a = 0.043 after interim analysis), UAS7 improved (difference -5.8 [95% CI, -11.4 to -0.3; P = .0390]), with a numerical trend in ISS7 (difference -2.9 [95% CI, -5.7 to -0.07; nominal P = .0449, not significant]), according to study authors. Across each study, pooled safety data revealed consistency between dupilumab and placebo, aligning with the "known dupilumab safety profile," per study results.2
Among biologic-naive CSU patients receiving background therapy with antihistamines, dupilumab met the primary and key secondary outcomes in the Study C phase 3 trial. This portion of the LIBERTY-CUPID clinical program enrolled 151 children and adults randomize dupilumab (n = 74) or placebo (n = 77) added to standard-of-care H1 antihistamines.d to receive dupi4
According to results at the 24-week mark, dupilumab demonstrated an 8.64-point reduction in itch severity from baseline, compared to a 6.10-point reduction with placebo (P = .02), as well as a 15.86-point reduction in urticaria activity severity versus an 11.21-point reduction with placebo (P = .02).4
In addition, "30% of Dupixent-treated patients reported no urticaria (complete response), compared to 18% of those on placebo (P =.02)," Sanofi stated in a September 11, 2024 press release.4
References:
1. Dupixent (dupiluab) sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria (CSU). Regeneron Pharmaceuticals. Press release. November 15, 2024. Accessed November 15, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-sbla-accepted-fda-review-treatment-chronic
2. Maurer M, Casale TB, Saini SS, et al. Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials. J Allergy Clin Immunol. 2024 Jul;154(1):184-194. doi: 10.1016/j.jaci.2024.01.028. Epub 2024 Feb 29. PMID: 38431226
3. Dupixent (dupiluab) significantly improved itch and hives in patients with chronic spontaneous urticaria, a step forward in demonstrating the role of type 2 inflammation in these patients. Regeneron Pharmaceuticals. Press release. July 29, 2021. Accessed November 15, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-significantly-improved-itch-and-hives/
4. Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU. Sanofi. Press release. September 11, 2024. Accessed November 15, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-11-05-05-00-2944239
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