Regeneron Pharmaceuticals And Sanofi Announce FDA Approval For Dupixent In The U.S. As First And Only Treatment For Adolescents With Chronic Rhinosinusitis With Nasal Polyps

Author: Benzinga Newsdesk | September 13, 2024 12:17pm

Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP

 

Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps

Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions

TARRYTOWN, N.Y. and PARIS, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This approval expands the initial June 2019 FDA approval in CRSwNP for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.

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