FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for Urticaria

Sanofi (SNY) and partner Regeneron (REGN) announced that the FDA has accepted their resubmitted supplemental biologics license application (sBLA) seeking approval of Dupixent for the treatment of chronic spontaneous urticaria (CSU).The sBLA seeks approval for CSU in people aged 12 years and older whose disease is not adequately controlled with existing therapies like H1 antihistamines. The FDA’s decision on the sBLA is expected on April 18, 2025.The FDA had issued a complete response letter (CRL) for the fi ...