On 15 November 2024, Regeneron and Sanofi announced that the US FDA has accepted for review their resubmitted supplemental Biologics Licence Application (sBLA) for Dupixent® (dupilumab) for patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The FDA’s target action date is 18 April 2025.
Regeneron and Sanofi had received a Complete Response Letter from the FDA in October 2023 requiring further efficacy data for the use of Dupixent® for CSU.
The resubmitted sBLA was supported by data from the LIBERTY-CUPID Phase 3 clinical program. This included a confirmatory phase 3 study of Dupixent® which met the primary and key secondary endpoints for treatment of patients with uncontrolled, biologic-naïve CSU receiving background therapy with antihistamines.
Japan was the first country in the world to approve Dupixent® for CSU in February 2024.
In October 2024, Sanofi reported that sales of Dupixent® for Q3 2024 had increased globally by 24% to €3.5 billion and were expected to total about €13bn for the full year.