Category: Approval/Launch Region: North America · United States Company: Pfizer Inc

US FDA approves Pfizer sNDA for Cibinqo expanding its indication to include adolescents with refractory, moderate-to-severe AD

US FDA approves Pfizer sNDA for Cibinqo expanding its indication to include adolescents with refractory, moderate-to-severe AD
Pfizer Inc. announced that the United States (US) Food and Drug Administration (FDA) approved its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib), expanding its indication to include adolescents (12 to <18 years) with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Cibinqo was previously approved only for the treatment of adults 18 years and older.

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