Regeneron, Sanofi label expansion for Dupixent under FDA priority review
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Regeneron (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) announced Tuesday that the U.S. FDA granted priority review for a supplemental Biologics License Application ((sBLA)) targeted at expanding the label for asthma therapy Dupixent.
The sBLA is aimed at winning FDA authorization to market Dupixent for children aged 1 to 11 years with eosinophilic esophagitis ((EoE)), an inflammatory disease that impacts the ability to eat. The monoclonal antibody is already approved in the U.S. for older children and adults with EoE.

The FDA has issued January 31, 2024, as the target action date for its review.
The sBLA is backed by data from the companiesâ Phase 3 EoE KIDS trial for children aged 1 to 11. Part A of the study met the main goal as patients on Dupixent reached histological disease remission at 16 weeks compared to those on placebo.
In Part B, which evaluated the treatment for an additional 36 weeks, the histological remission was maintained for 52 weeks, a secondary goal of the study.



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