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Dupixent FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 8, 2021.

FDA Approved: Yes (First approved March 28, 2017)
Brand name: Dupixent
Generic name: dupilumab
Dosage form: Injection
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Atopic Dermatitis, Asthma, Chronic Rhinosinusitis with Nasal Polyps

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist used for the treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis (CRSwNP).

  • Dupixent is 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 of patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.
    • as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).
  • Dupixent is supplied as a single-dose pre-filled pen and a single-dose pre-filled syringe. Dupixent is administered via subcutaneous injection every 2-4 weeks. The pre-filled pen is only for use in adults and adolescents aged 12 years and older.
  • Common adverse reactions in atopic dermatitis patients include injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, and dry eye. Common adverse reactions in asthma patients include injection site reactions, oropharyngeal pain, and eosinophilia. Common adverse reactions in Chronic Rhinosinusitis with Nasal Polyposis patients include injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.

Development Timeline for Dupixent

DateArticle
Oct 20, 2021Approval  FDA Expands Approval of Dupixent (dupilumab) to Include Children Aged 6 to 11 Years with Moderate-to-severe Asthma
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.