Express is expected to benefit infants and young children with eczema, Dupixent is granted priority review

▎WuXi AppTec Content Team Editor On February 10, 2022, Regeneron and Sanofi announced that the U.
S.
Food and Drug Administration (FDA) has granted Dupilumab (dupilumab, English trade name Dupixent) a supplemental biological product Priority review eligibility for licensure application (sBLA) as add-on maintenance therapy in children 6 months to 5 years of age with moderate-to-severe atopic dermatitis
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Once approved, dupilumab will be the first biologic approved for the treatment of uncontrolled moderate-to-severe atopic dermatitis in this group, the press release states
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 Atopic dermatitis is a chronic type 2 inflammatory skin disease that occurs in 85 to 90% of patients before age 5 and often persists into adulthood
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Symptoms include intense, persistent itching and skin lesions that cover most of the body, leading to dry, cracked, painful, red or darkened skin, crusting and bleeding, and an increased risk of skin infections
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Moderate-to-severe atopic dermatitis may also significantly affect the quality of life of young children, their parents, and caregivers
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The current treatment options for this age group are mainly topical corticosteroids (TCS), which may have safety risks and may impair normal growth with long-term use
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Dupilumab is a fully humanized monoclonal antibody that selectively inhibits key interleukin 4 (IL-4) and interleukin 13 (IL-13) signaling pathways and reduces the pathological response of type 2 inflammation , Mechanistically treat type 2 inflammation-related diseases, such as asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis
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This sBLA submission is supported by positive data from a pivotal Phase 3 clinical trial
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The trial met all primary and secondary endpoints, and at week 16, the addition of dupilumab to TCS significantly reduced patients' overall disease severity and improved significantly compared with standard care Skin symptom clearance, pruritus, and health-related quality of life indicators in patients
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Specifically, 28% of subjects in the dupilimumab group achieved clear or nearly clear skin compared to the placebo group (4%, p≤0.
0001), more than 7 times the rate of TCS monotherapy patients
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Also, 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 pruritus compared to the placebo group (11%)
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The safety results were generally consistent with the safety profile of dupilumab in patients with atopic dermatitis aged 6 years and older
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The most common adverse events in the dupilumab group included conjunctivitis and herpesvirus infection
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Reference: [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:// news-releases/fda-accepts-dupixent-dupilumab-for-priority-review-in-children-aged-6-months-to-5-years-with-moderate-to-severe-atopic-dermatitis-301479373.
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