FDA Approves Dupixent (dupilumab) as First Biologic for Infants and Toddlers with Moderate-to-Severe Atopic Dermatitis

Today, Regeneron and Sanofi announced that the U.S. FDA has approved dupilumab (brand name: Dupixent) for the treatment of pediatric patients aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose condition is not adequately controlled by topical therapies or who are not suited for these treatments. The press release noted that dupilumab is the first biologic approved to treat moderate-to-severe atopic dermatitis in patients ranging from infants to adults.

Atopic Dermatitis, Also Known as Eczema, Is a Chronic Type 2 Inflammatory Skin DiseaseAtopic dermatitis, also known as eczema, is a chronic type 2 inflammatory skin disease. About 85-90% of patients develop symptoms before the age of 5, and these symptoms often persist into adulthood. Symptoms include intense and persistent itching, as well as skin lesions covering most parts of the body, leading to dry, cracked, painful, red or darkened, crusted, and bleeding skin, along with an increased risk of skin infections. Moderate to severe atopic dermatitis can also significantly impact the quality of life for young children, their parents, and caregivers. The current treatment options for this age group mainly consist of topical corticosteroids (TCS), which may pose safety risks, as long-term use could impair normal growth.

Dupilumab is a fully humanized monoclonal antibody that can selectively inhibit the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13), reducing pathological responses of type 2 inflammation, and treating type 2 inflammation-related diseases mechanistically, such as asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and atopic dermatitis.

This approval is mainly based on data from a Phase 3 clinical trial. In this trial, infant and toddler patients received dupilumab and low-potency TCS treatment, or TCS treatment alone. The trial results showed that at week 16, the dupilumab + TCS group:

28% of patients achieved complete or near-complete clearance of skin symptoms, compared to 4% in the control group.

53% of patients achieved a 75% or greater improvement in disease severity compared to baseline, versus 11% in the control group.

48% of patients achieved clinically meaningful reduction in itching, compared to 9% in the control group.

The safety observed in children aged 6 months to 5 years was similar to the results observed in children with atopic dermatitis aged 6 years and above.

"Previously, treatment options for children aged 6 and under with moderate to severe atopic dermatitis in the U.S. were limited to topical corticosteroids. Their long-term use is associated with significant safety risks. Patients and their families are in urgent need of better medications," said Dr. Naimish Patel, Global Head of Immunology and Inflammation Development at Sanofi. "These infants and young children, along with their families, often struggle to cope with the impact of itching on their bodies and all aspects of daily life. Today’s approval means that dupilumab can benefit some of the youngest patients."

References:

[1] FDA Approves Dupixent® (dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis. Retrieved June 7, 2022, from https://www.prnewswire.com/news-releases/fda-approves-dupixent-dupilumab-as-first-biologic-medicine-for-children-aged-6-months-to-5-years-with-moderate-to-severe-atopic-dermatitis-301563406.html

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