Shots:

• The BT designation is based on Part A of P-III study assessing Dupixent (300mg) in 81 patients aged ≥12yrs. with EoE for 24wks.
• The Part A of P-III study met its co-1EPs and 2EPs i.e. reduction in symptoms- esophageal inflammation- abnormal endoscopic findings in the esophagus and has demonstrated safety results consistent with the known safety profile of Dupixent in its approved indications
• The P-III study is ongoing with additional patients enrolling in Part B as well as patients continuing in a 28wks. extended active treatment period (Part C) after completing either Part A or B. Dupixent is the first and only biologic to show positive P-III results in patients aged ≥12yrs. with EoE and has received the US FDA’s ODD in 2017

­ Ref: Sanofi | Image: Law