Pfizer announces FDA approval of sNDA for CIBINQO

Pfizer announced that the United States Food and Drug Administration approved its supplemental New Drug Application for CIBINQO, expanding its indication to include adolescents with refractory, moderate-to-severe atopic dermatitis 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. The CIBINQO prescribing information was updated to include data from JADE TEEN, a Phase 3, randomized, placebo-controlled clinical trial. JADE TEEN, which supported the expanded indication, evaluated both the 100 mg and 200 mg doses of CIBINQO versus placebo in adolescents 12 to less than18 years of age with moderate-to-severe AD while also on background therapy with topical medications. The trial evaluated measures of improvements in skin clearance, itch, disease extent, and severity, including the Investigator Global Assessment, Peak Pruritus Numerical Rating Scale, and Eczema Area and Severity Index.