Medication Monitor

Generic Name (Trade Name—Company)
March 13, 2019


Eczema drug has new indication for patients aged 12 to 17

Regeneron and Sanofi announced FDA approval of dupilumab for patients aged 12 to 17 years with moderate to severe atopic dermatitis (eczema) 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.

The agent is a targeted biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that may play a central role in type 2 inflammation that underlies atopic dermatitis and several other allergic diseases.

Dupixent has been studied in more than 7,000 patients aged 12 years and older in more than 30 clinical trials. Its safety profile in the adolescent trial was similar to the safety profile from trials in adults with atopic dermatitis and consistent through 52 weeks.

The most common adverse events were injection-site reactions; eye and eyelid inflammation, including redness, swelling; and itching; oropharyngeal pain; and cold sores in the mouth or on the lips.

Dupixent comes in two doses (200 mg and 300 mg), each as a prefilled syringe. Dupixent is intended for S.C. injection and is given every other week following an initial loading dose. It can be given in a clinic or, for convenience, at home by self-administration after training by a health professional.

Dupixent is also approved for treatment of adult patients with moderate to severe atopic dermatitis that is not well controlled with topical prescription drugs or who cannot use topical therapies; and for use with other asthma medications for maintenance treatment of moderate to severe asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines.