On 11 September 2024, Sanofi and Regeneron announced that a confirmatory phase 3 study of Dupixent® (dupilumab) met the primary and key secondary endpoints for treatment of patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) receiving background therapy with antihistamines.
The phase 3 data will be submitted by Sanofi and Regeneron to FDA by the end of 2024 to support the resubmission of their sBLA for Dupixent® for CSU. This follows the FDA’s October 2023 Complete Response Letter requiring further efficacy data.
Japan was the first country in the world to approve Dupixent® for CSU in February 2024.