Dupilumab approved by FDA for children with atopic dermatitis


The U.S. FDA has approved dupilumab (Dupixent, Sanofi and Regeneron) for the treatment of atopic dermatitis in children 6-11 years, making it the first biologic approved for atopic dermatitis in this particular age group.

The United States Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Sanofi and Regeneron) for moderate-to-severe atopic dermatitis (AD) in children 6 to 11 years whose disease is not well controlled on topical prescription medication.1

This approval marks dupilumab as the only FDA-approved biologic for patients 6-11 years, according to a press release.2

MORE: Molecular study highlights drug differences in atopic dermatitis

The biologic is a fully-human monoclonal antibody that inhibits interleukin-4 (IL-4) and IL-13 signaling.

“This approval brings the paradigm-changing efficacy and established safety profile of Dupixent to children with moderate-to-severe atopic dermatitis,” says George D. Yancopoulos, M.D., Ph.D., cofounder, president and chief scientific officer at Regeneron.

The decision follows results from a phase 3 trial investigating the safety and efficacy of dupilumab in patients 6-11 years as a combination therapy with topical corticosteroids (TCS) versus TCS alone.

The study demonstrated positive results with an 84% increase in average Eczema Area and Severity Index (EASI) scores from baseline in patients who were given dupilumab every four weeks and 80% in those received it every two weeks versus 49% and 48% for TCS, respectively.

Meanwhile, 75% of patients who received dupilumab every four weeks achieved EASI75 in addition to 75% of patients who received dupilumab every two weeks compared to 28% and 26% for TCS, respectively.

Dupilumab also showed superiority over TCS alone in skin clearance and reduction in itch intensity in the Peak Pruritis Numerical Rating Scale. The safety profile was also consistent with past studies.

RELATED: Dupilumab safe for adolescents with atopic dermatitis

“We continue to study Dupixent in even younger children with uncontrolled moderate-to-severe atopic dermatitis from 6 months to 5 years old, as well as in children with uncontrolled, persistent asthma. Additionally, we are investigating Dupixent in other diseases driven by type 2 inflammation including eosinophilic esophagitis, food and environmental allergies, chronic obstructive pulmonary disease, and other dermatologic diseases,” says Dr. Yancopoulos.

More information on the study and approval can be found on drugtopics.com.


1. Barrett, J. (2020, May 26). FDA Approves Dupilumab for Atopic Dermatitis in Children. Retrieved May 26, 2020, from https://www.drugtopics.com/autoimmune-diseases/fda-approves-dupilumab-atopic-dermatitis-children

2. FDA approves Dupixent® (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis. (2020, May 26). Retrieved May 26, 2020, from http://www.news.sanofi.us/2020-05-26-FDA-approves-Dupixent-R-dupilumab-as-first-biologic-medicine-for-children-aged-6-to-11-years-with-moderate-to-severe-atopic-dermatitis

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