Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for Priority Review the supplemental Biologics License Application, or sBLA, for Dupixent as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis, or CRSwNP. The target action date for the FDA decision is September 15. Dupixent is currently approved as an add-on maintenance treatment for adults with CRSwNP whose disease is not adequately controlled.
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