Posted by Michael Wonder on 14 Sep 2020
FDA grants Dupixent (dupilumab) breakthrough therapy designation for eosinophilic oesophagitis
14 September 2020 - There are currently no FDA approved treatments for this chronic type 2 inflammatory disease that damages the oesophagus and impacts patients’ ability to swallow and eat
The U.S. FDA has granted breakthrough therapy designation to Dupixent (dupilumab) for the treatment of patients 12 years and older with eosinophilic oesophagitis.
The designation for this investigational use is based on positive results from Part A of a Phase 3 trial in patients with eosinophilic oesophagitis.
