FDA Expands Approval of Dupixent to Children 6 Months and Older With Moderate-to-Severe Atopic Dermatitis

Dupixent was already approved for patients 6 years and older. The new approval makes the drug available to children 6 months to 5 years whose atopic dermatitis is inadequately controlled.

The FDA expanded use of Dupixent (dupilumab) to include children as young as 6 months with moderate-to-severe atopic dermatitis (AD). The FDA has approved the drug for children 6 months to 5 years whose AD is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The European Medicines Agency is reviewing Dupixent for the same indication.

According to Sanofi, the manufacturer of Dupixent, 85% to 90% of patients develop the first symptoms of AD before 5 years, and more than 75,000 children 5 years and younger in the United States have uncontrolled moderate-to-severe AD.

“Moderate-to-severe atopic dermatitis in babies and young children is more than just a rash — the intense itch can make them scratch uncontrollably throughout the day and night and cause their skin to crack and bleed,” Julie Block, president and CEO of the National Eczema Association, said in a statement. “Caregivers do their best to manage skincare routines multiple times a day, but for many, topical treatments are not enough. We’re pleased to see how scientific innovation and research continues to address unmet needs for the atopic dermatitis community, and we’re hopeful for the positive impact Dupixent can have for these children and their families.”

The approval was based on the phase 3 trial LIBERTY AD PRESCHOOL, which evaluated Dupixent every four weeks plus low-potency topical corticosteroids ( or placebo. The trial evaluated 162 children, 83 who received Dupixent and 79 who received placebo. The average age was 3.8 years and 61% were male.

After 16 weeks, 28% of patients had achieved clear or almost-clear skin compared with 4% receiving placebo. More than half (53%) had achieved a 75% or greater improvement in overall disease severity from baseline compared with 11% on placebo.

“Young children with moderate-to-severe atopic dermatitis are a significantly underserved population of patients, who spend vulnerable years of their lives suffering through the relentless and far-reaching effects of this chronic disease. Dupixent has changed the atopic dermatitis treatment paradigm — significantly clearing skin and reducing itch — by targeting an underlying cause of this disease without broadly suppressing the immune system,” George D. Yancopoulos, M.D., Ph.D., president and chief scientific officer of Regeneron, which developed Dupixent jointly with Sanofi. He added that the “approval brings the proven efficacy and, importantly, well-established safety profile of Dupixent to these young children, making it the first of its kind to be approved for any U.S. patient aged 6 months or older living with this debilitating disease.”

The safety profile for children 6 months to 5 years was similar to that seen in patients 6 years and older. The most common adverse events were hand-foot-and-mouth disease (5%) and skin papilloma (2%) and none of these cases were enough to discontinue treatment.

Children who completed the randomized, double-blind, placebo-controlled part of the trial where eligible to enroll in an open-label extension trial to assess the safety and efficacy of long-term treatment.

Dupixent is already approved for moderate-to-severe AD in patients 6 years and older, as an add-on maintenance treatment in patients 6 years and older with moderate-to-severe asthma, as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps and, most recently, to treat eosinophilic esophagitis in patients 12 years and older.