Posted by Michael Wonder on 20 Oct 2023
Regeneron and Sanofi provide update on Dupixent (dupilumab) sBLA for chronic spontaneous urticaria
20 October 2023 - Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has issued a complete response letter for the supplemental biologics license application for Dupixent (dupilumab) in chronic spontaneous urticaria.
The complete response letter states that additional efficacy data are required to support an approval; it did not identify any issues with safety or manufacturing. An on-going clinical trial (Study C) continues to enrol patients, with results expected in late 2024 that are anticipated to provide the additional efficacy data.
