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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

DateArticle
Jun 19, 2020Approval FDA Approves New Dupixent (dupilumab) Pre-Filled Pen Designed to Support More Convenient Self-Administration
May 26, 2020Approval FDA Approves Dupixent (dupilumab) as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis
Jun 26, 2019Approval FDA Approves Dupixent (dupilumab) for Chronic Rhinosinusitis with Nasal Polyposis
Mar 11, 2019Approval FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents
Oct 19, 2018Approval FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Asthma
Mar 28, 2017Approval FDA Approves Dupixent (dupilumab) for Eczema
Sep 26, 2016Sanofi and Regeneron Announce Dupilumab Biologics License Application Accepted for Priority Review by U.S. FDA

Further information

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