Posted by Michael Wonder on 04 Apr 2022
FDA accepts Dupixent (dupilumab) for priority review in patients aged 12 years and older with eosinophilic oesophagitis
4 April 2022 - If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis.
The U.S. FDA has accepted for priority review the supplemental biologics license application for Dupixent (dupilumab) 300 mg weekly to treat adult and paediatric patients aged 12 years and older with eosinophilic esophagitis, a chronic and progressive type 2 inflammatory disease that damages the oesophagus and impairs the ability to swallow.
The target action date for the FDA decision on this investigational use is 3 August 2022.
