Posted by Michael Wonder on 03 Jun 2024
Update on FDA priority review of Dupixent (dupilumab) for the treatment of COPD patients with type 2 inflammation
31 May 2024 - Regeneron Pharmaceuticals and Sanofi today announced the US FDA has extended by three months the target action date of its priority review of the supplemental biologics license application for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease.
The revised target action date is 27 September 2024. The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.
