Regeneron And Sanofi's Dupixent (dupilumab) sBLA For Treatment Of Eosinophilic Esophagitis In Children Aged 1 To 11 Accepted For FDA Priority Review; The Target Action Date Is January 31, 2024
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The FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab), a drug developed by Regeneron and Sanofi, for the treatment of eosinophilic esophagitis in children aged 1 to 11.
September 26, 2023 | 6:50 am
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POSITIVE IMPACT
Regeneron's drug Dupixent has been accepted for FDA priority review, potentially expanding its market.
The acceptance of Dupixent for FDA priority review indicates a positive regulatory development for Regeneron. If approved, it could expand the market for Dupixent, potentially boosting Regeneron's revenues.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100
POSITIVE IMPACT
Sanofi's drug Dupixent has been accepted for FDA priority review, potentially expanding its market.
The acceptance of Dupixent for FDA priority review indicates a positive regulatory development for Sanofi. If approved, it could expand the market for Dupixent, potentially boosting Sanofi's revenues.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100