Regeneron, Sanofi announce FDA accepts Dupixent sBLA for review

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License Application, or sBLA, for Dupixent to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria, or CSU, whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025. The resubmitted sBLA is supported by data from the multi-trial, LIBERTY-CUPID Phase 3 clinical program for Dupixent in CSU. The sBLA adds results from Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Study C, the second LIBERTY-CUPID pivotal trial in biologic-naive patients, met its primary and key secondary endpoints confirming results seen in the previous Study A. Results showed Dupixent significantly reduced itch and urticaria activity. Safety results in all LIBERTY-CUPID Phase 3 trials were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent compared to placebo were injection site reactions and COVID-19 infection.