Dupixent FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 2, 2022.
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, Eosinophilic Esophagitis, Prurigo Nodularis
Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist used for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis.
- Dupixent is indicated for the treatment of:
- Atopic Dermatitis - for the treatment of adult and pediatric patients aged 6 months 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.
- Asthma - as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.
- Chronic Rhinosinusitis with Nasal Polyposis - as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP).
- Eosinophilic Esophagitis - for the treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE).
- Prurigo Nodularis - for the treatment of adult patients with prurigo nodularis (PN).
- 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.
- Warnings and precautions associated with Dupixent include hypersensitivity reactions, conjunctivitis and keratitis, eosinophilic conditions, arthralgia, and parasitic (helminth) infections.
- 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.
Common adverse reactions in eosinophilic esophagitis patients include injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.
Common adverse reactions in prurigo nodularis patients include nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea.
Development timeline for Dupixent
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