French healthcare company Sanofi S.A. (Euronext Paris: SAN) (Nasdaq: SNY) said on Tuesday that the US Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents.

CSU is an inflammatory skin condition driven in part by type 2 inflammation, which causes sudden and debilitating hives and swelling on the skin. Swelling may occur most commonly on the face, hands and feet, but can also affect the throat and upper airways. CSU is typically treated with H1 antihistamines, medicines that target histamine-1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled in up to 50% of patients.

More than 300,000 people in the United States suffer from CSU that is inadequately controlled by antihistamines, Sanofi said. The sBLA is supported by data from two Phase 3 trials which evaluated Dupixent in two different patient populations with uncontrolled CSU.

The target action date for the FDA decision is 22 October 2023.

Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. It is being jointly developed by Sanofi and Regeneron Pharmaceuticals Inc (Nasdaq: REGN) under a global collaboration agreement.