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On February 10, 2022, Regeneron and Sanofi announced that the U.
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
Dupilumab is a fully humanized monoclonal antibody that selectively inhibits the 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
This sBLA submission is supported by positive data from a pivotal Phase 3 clinical trial
Specifically, 28% of subjects in the dupilumab group achieved clear or almost clear skin compared to the placebo group (4%, p≤0.
References:
[1] FDA Accepts Dupixent® (dupilumab) for Priority Review in Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis.