The U.S. Food and Drug Administration (FDA) recently accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent, Sanofi & Regeneron) to treat adults and pediatric patients aged 12 and up with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamines. The new Prescription Drug User Fee Act (PDUFA) target action date for the FDA decision is April 18, 2025. Thomas Casale, MD, a Professor of Medicine and Pediatrics and Chief of Clinical and Translational Research in the Division of Allergy/Immunology at the Morsani College of Medicine of the University of South Florida in Tampa, FL, reviews the data that supported the SBLA resubmission. “We need more good therapies for these patients because of the big effect [that CSU has] their quality of life, their ability to sleep, [and] the ability to interact with other people, so it’s very exciting that … the clinically meaningful and statistically significant efficacy demonstrated at 24 weeks in patients who were symptomatic despite the use of H1 antihistamines confirmed the results of the initial study and now led to the FDA reviewing this as another possible indication for this drug.”
