FDA accepts for review Regeneron/Sanofi's Dupixent application for inflammatory skin condition
Eik Scott


Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) announce that the FDA has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the current standard of care, H1 antihistamine treatment.

The target action date for the FDA decision is October 22, 2023.
CSU is an inflammatory skin condition which causes sudden and debilitating hives and swelling on the skin.
The sBLA is supported by data from two Phase 3 trials (LIBERTY-CUPID Studies A and B) evaluating Dupixent in two different patient populations with uncontrolled CSU.
The potential use of Dupixent in CSU is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.
In addition, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including pediatric EoE, atopic hand and foot dermatitis, chronic inducible urticaria-cold, CSU, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid.