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Dupixent Approved for Chronic Rhinosinusitis With Nasal Polyps

The Food and Drug Administration (FDA) has approved Dupixent (dupilumab; Sanofi and Regeneron) as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The approval was based on data from two phase 3 randomized, double blind, placebo controlled trials (SINUS-24 and SINUS-52) that evaluated the safety and efficacy…
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Dupixent sBLA Gets Priority Review for Chronic Rhinosinusitis With Nasal Polyps Indication

Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP). The sBLA included data from two phase 3 randomized, double-blind, placebo-controlled trials (SINUS-24…
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Dupilumab Gets Priority Review for Adolescent Atopic Dermatitis

Dupixent is also being assessed in other allergic/inflammatory conditions, including pediatric atopic dermatitis, pediatric asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, grass allergy, and peanut allergy.