Dupilumab Receives PDUFA Date for Pediatric Eczema


The FDA will rule on the type 2 inflammation-targeting biologic for another indication this May.


The first biologic for pediatric moderate-to-severe atopic dermatitis (eczema) may be on the market by this summer.

The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) as an add-on maintenance therapy in children aged 6-11 years old with moderate-to-severe, inadequately controlled eczema.

The Regeneron Pharmaceuticals-Sanofi fully human monoclonal antibody was accepted for Priority Review by the FDA, granting its application a PDUFA action date of May 26, 2020.

The sBLA is supported by findings from a pivotal phase 3 trial which shows children treated with a combination of dupilumab plus topical corticosteroids reported significantly improved marks in overall disease severity, skin clearing, itching, and health-related quality of life, versus lone topical corticosteroids.

The findings, which will be presented at an upcoming medical meeting, show a safety profile of dupilumab which is consistent with the profile previous documented in treated older patients. The most common adverse events among treated patients included conjunctivitis, nasopharyngitis, and injection site reactions.

Dupilumab is an interleukin-4 and -13 (IL4, IL13) targeting biologic that has been previously approved for moderate-to-severe atopic dermatitis and asthma in patients aged 12 years and older, and severe chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults.

Its efficacy has been observed in patients who suffer from type 2 inflammation-related conditions, and it is currently being investigated for treatment of eosinophilic esophagitis, food and environmental allergies, and chronic obstructive pulmonary disease (COPD) among other indications.

In an interview with HCPLive®, Melodie Young, MSN, ANP-c, of Modern Dermatology in Dallas, recalled a young patient burdened with eczema for at least 10 years receiving investigative dupilumab for his condition.

One month following treatment initiation, he returned to her practice with gradually improved skin clearance and significant improvement in quality-of-life symptoms including quality of sleep.

“The disease had that sort of a life-changing impact on him, and he literally looks like a younger, healthy version of himself now,” Young said. “That’s the way that the disease can just totally be gone—it just melts away. And we hear those stories all the time.”

The FDA previously granted Breakthrough Therapy designation to dupilumab for the treatment of severe atopic dermatitis in children aged 6 months to 11 years not well-controlled by topical prescription medication.

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Elizabeth Cerceo, MD | Credit: ACP
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