FDA approves supplemental new drug application for Cibinqo in atopic dermatitis.- Pfizer

The Cibinqo prescribing information was updated to include data from JADE TEEN, a Phase III, 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 <18 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 (iga), peak pruritus numerical rating scale (pp-nrs), and eczema area and severity index (easi).></18>

Data from the robust clinical trial program included in the prescribing information now stems from five randomized, placebo-controlled clinical trials and a long-term extension study with more than 1,600 patients treated with Cibinqo. Across the trials to date, Cibinqo demonstrated a consistent safety profile and profound improvements in skin clearance, extent of disease, and severity as well as rapid improvement in itch after two weeks, for some people living with AD versus placebo, including adolescents. Across trials, the most common adverse events reported in at least 1% of patients treated with Cibinqo for up to 16 weeks included nasopharyngitis (12.4% with Cibinqo 100 mg, 8.7% with Cibinqo 200 mg, and 7.9% with placebo), nausea (6%, 14.5%, and 2.1%, respectively), and headache (6%, 7.8%, and 3.5%, respectively).