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New Indication Alert: Dupixent® (Dupilumab) Receives First US Approval for Adolescents with CRSwNP

Sep 16, 2024

On 13 September 2024, Regeneron and Sanofi announced that their Dupixent® (dupilumab) has received FDA approval as an add-on maintenance treatment for patients aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).  This follows the FDA’s May 2024 acceptance of the sBLA for Dupixent® for priority review for adolescents with CRSwNP.

On 25 July 2024, Sanofi revealed that its worldwide sales of Dupixent® grew by 29.2% to €3,303 million in the second quarter of 2024.  Sanofi expects the product to generate revenue of about €13 billion for 2024.