FDA Accepts sBLA of Dupilumab for the Treatment of Chronic Spontaneous Urticaria

Image Credit: © Araki Illustrations - stock.adobe.com

Regeneron Pharmaceuticals, Inc. and Sanofi announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) in treating uncontrolled chronic spontaneous urticaria (CSU)¹. The IL-4 and IL-13 inhibitor is intended for adults and children aged 12 years and older who have not previously reached controlled disease status with H1 antihistamine treatment.

The resubmission is supported by positive results from the phase 3 LIBERTY-CUPID clinical trials (Study A, Study B, and Study C). According to the press release, “Study A and Study C were conducted in CSU patients who were uncontrolled on standard-of-care antihistamines while Study B was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab.”¹

Specifically, the sBLA adds results from Study C, which met its primary and secondary endpoints in biologic-naïve patients.² Nearly half of patients reached well-controlled disease status and saw a significant reduction in itching and hives, confirming results that were first observed in Study A.

The investigators noted adverse effects such as injection site reactions and COVID-19 diagnoses, but these were observed in both patient groups. Adverse events were more commonly found with dupilumab compared to placebo (≥5%). These results are consistent with the existing safety profile of dupilumab’s approved indications.

The target action date for the FDA decision is April 18, 2025. If approved, this would be the first targeted therapy for CSU in more than 10 years.

References

1. Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU). News release. Regeneron. 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. Dupixent® (dupilumab) late-breaking positive phase 3 data in chronic spontaneous urticaria to be presented at ACAAI. News release. Regeneron. October 24, 2024. Accessed November 15, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-late-breaking-positive-phase-3-data-chronic