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Regeneron and Sanofi Receive CRL from FDA for Dupixent® (dupilumab) in CSU

Oct 20, 2023

Regeneron and Sanofi announced that that FDA has issued a Complete Response Letter (CRL) regarding the sBLA for Dupixent® (dupilumab) for use in chronic spontaneous urticaria (CSU).  Regeneron and Sanofi said FDA’s CRL requires additional efficacy data to support an approval, but did not identify any issues with safety or manufacturing.  The companies confirmed that the ongoing clinical trial is enrolling patients, and results are expected in late 2024.  According to Regeneron and Sanofi, these trials should provide the additional efficacy data required by the FDA.

On 11 July 2023 Sanofi received MA for Dupixent® in India to treat moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are contraindicated.