- 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
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