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Sanofi and Regeneron to Submit New Data to Support sBLA for Dupixent® (Dupilumab) to Treat CSU

Sep 11, 2024

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.