Regeneron and Sanofi Report the US FDA Acceptance of sBLA for Priority Review of Dupixent to Treat Eosinophilic Esophagitis in Children Aged 1-11Years
Shots:
- The US FDA has accepted the sBLA for Priority Review of Dupixent to treat children aged 1-11yrs. with EoE. The US FDA’s decision is expected in Jan 2024
- The sBLA was based on the P-III (EoE KIDS) trial (Parts A and B) evaluating Dupixent in children aged 1-11yrs. with EoE. In Part A, the trial met its 1EPs & showed that patients achieved histological disease remission at 16wks. for tiered dosing regimens based on body weight
- Part B, an active treatment extension period showed that Dupixent maintained histologic remission for 52wks. & led to increases in body weight for the age percentile. The safety results were consistent with the known safety profile of Dupixent in EoE indication for children and adults aged ≥12yrs.
Ref: Globenewswire | Image: Regeneron
Related News:- Sanofi and Regeneron Report P-III Trial (PRIME) and (PRIME2) Results of Dupixent (dupilumab) for the Treatment of Prurigo Nodularis
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