Sanofi & Regeneron Reports the US FDA’s Acceptance of sBLA for Priority Review of Dupixent (dupilumab) for Eosinophilic Esophagitis
Shots:
- The sBLA was based on the 2 P-III trials evaluating the efficacy & safety of Dupixent (300mg, qw) vs PBO in patients aged ≥12yrs. with EoE along with the results from a long-term extension trial. The US FDA’s decision is expected on Aug 3, 2022
- The results showed that the patients achieved an improvement in the signs & symptoms @24wks. including the ability to swallow & a reduction in eosinophil count. The safety results were consistent with the known safety profile of Dupixent in its approved indications
- If approved, Dupixent will be 1st treatment in the US for EoE. The therapy has received the BTD from the US FDA for the same indication in Sept 2020 & ODD in 2017
Ref: Sanofi | Image: Sanofi
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