Dupixent FDA Approval History
Last updated by Judith Stewart, BPharm on April 23, 2025.
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, COPD, Urticaria
Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist used for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease (COPD), and chronic spontaneous urticaria.
- 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 AD 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.
Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus.
- Chronic Rhinosinusitis with Nasal Polyps as an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
- Eosinophilic Esophagitis for the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE).
- Prurigo Nodularis for the treatment of adult patients with prurigo nodularis (PN).
- Chronic Obstructive Pulmonary Disease as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.
Limitations of Use: Not for the relief of acute bronchospasm.
- Chronic Spontaneous Urticaria for the treatment of adult and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.
Limitations of Use: Not indicated for other forms of urticaria. - 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.
- pre-filled pen for use in adult and pediatric patients aged 2 years and older.
- pre-filled syringe for use in adult and pediatric patients aged 6 months and older.
A caregiver or patient 12 years of age and older may inject Dupixent using the pre-filled syringe or pre-filled pen. In pediatric patients 12 to 17 years of age, the injection must be administered under the supervision of an adult. In pediatric patients 6 months to less than 12 years of age, the injection must be administered by a caregiver. - Warnings and precautions associated with Dupixent include hypersensitivity reactions, conjunctivitis and keratitis, eosinophilic conditions, psoriasis, arthralgia and psoriatic arthritis, and parasitic (helminth) infections.
- Common adverse reactions:
- in patients with atopic dermatitis (incidence ≥1%) include injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye, and eosinophilia.
- in patients with asthma (incidence ≥1%) include injection site reactions, oropharyngeal pain, and eosinophilia.
- in patients with chronic rhinosinusitis with nasal polyps (incidence ≥1%) include injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis.
- in patients with eosinophilic esophagitis (incidence ≥2%) include injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.
- in patients with prurigo nodularis (incidence ≥2%) include nasopharyngitis, conjunctivitis, herpes infection, dizziness, myalgia, and diarrhea.
- in patients with chronic obstructive pulmonary disease (incidence ≥2%) include viral infection, headache, nasopharyngitis, back pain, diarrhea, arthralgia, urinary tract infection, local administration reactions, rhinitis, eosinophilia, toothache, and gastritis.
- in patients with chronic spontaneous urticaria (incidence ≥2%) include injection site reactions.
Development timeline for Dupixent
Further information
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