Dupixent (dupilumab) sBLA accepted for FDA priority review for treatment of adolescents with chronic rhinosinusitis with nasal polyposis

Regeneron Pharmaceuticals

13 May 2024 - If approved, Dupixent would be the first treatment in the US indicated for adolescents aged 12-17 years with inadequately controlled CRSwNP, a condition driven in part by underlying type 2 inflammation that obstructs the sinuses and nasal passages and can lead to a loss of sense of smell.

Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has accepted for priority review the supplemental biologics license application for Dupixent (dupilumab) as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).

Read Regeneron Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Priority review , Dossier