Dupixent FDA Approval History
Reviewed by J.Stewart BPharm. Last updated on May 26, 2020.
FDA Approved: Yes (First approved March 28, 2017)
Brand name: Dupixent
Generic name: dupilumab
Dosage form: Injection
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Atopic Dermatitis; Asthma; Chronic Rhinosinusitis with Nasal Polyposis
Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated:
- for the treatment of patients aged 6 years and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.
- as an add-on maintenance treatment in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitation of Use: Not for the relief of acute bronchospasm or status asthmaticus.
- as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).
Development Timeline for Dupixent
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