Dupixent Granted FDA Priority Review for Moderate-to-Severe Atopic Dermatitis in Infants and Toddlers Aged 6 Months to 5 Years

On February 10, 2022, Regeneron and Sanofi announced that the U.S. FDA has granted priority review status to the supplemental Biologics License Application (sBLA) for dupilumab (trade name: Dupixent) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. The press release noted that, if approved, dupilumab will become the first biologic therapy authorized to treat uncontrolled moderate-to-severe atopic dermatitis in this population.

Atopic Dermatitis: A Chronic Type 2 Inflammatory Skin ConditionAtopic dermatitis is a chronic type 2 inflammatory skin condition. Symptoms appear in 85-90% of patients before the age of five and often persist into adulthood. Symptoms include intense, persistent itching and skin lesions covering most parts of the body, leading to dry, cracked, painful, red or darkened, crusted, and bleeding skin, as well as 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. Current treatment options for this age group mainly consist of topical corticosteroids (TCS), which may pose safety risks, and long-term use could impair normal growth.

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

This sBLA submission was supported by positive data from a pivotal Phase 3 clinical trial. The trial met all primary and secondary endpoints, showing that adding dupilumab to TCS significantly reduced overall disease severity and significantly improved skin clearance, itch, and health-related quality of life measures at week 16 compared to standard treatment.

Specifically, compared with the placebo group (4%, p≤0.0001), 28% of subjects in the dupilumab group achieved clear or almost clear skin, more than 7 times that of patients treated with TCS monotherapy. Moreover, compared with the placebo group (11%), 53% of patients in the dupilumab group achieved EASI-75 (p≤0.0001), with a 70% reduction in overall disease severity and a 49% reduction in itching. The safety results were generally consistent with the safety profile of dupilumab in treating atopic dermatitis patients aged 6 years and above. The most common adverse events in the dupilumab group included conjunctivitis and herpesvirus infection.

References:

[1] FDA Accepts Dupixent® (dupilumab) for Priority Review in Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis. Retrieved February 10, 2022, from https://www.prnewswire.com/news-releases/fda-accepts-dupixent-dupilumab-for-priority-review-in-children-aged-6-months-to-5-years-with-moderate-to-severe-atopic-dermatitis-301479373.html

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