Pfizer announced that the United States (U.S.) 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.

“This is a meaningful advancement for the many adolescents across the U.S. who are affected by the persistent itching and discomfort that accompanies uncontrolled moderate-to-severe atopic dermatitis,” said Lawrence Eichenfield, MD, Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital in San Diego. “The extended indication of CIBINQO offers potential relief for young atopic dermatitis patients in need and their families.”

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).

“Moderate-to-severe atopic dermatitis can have debilitating physical and emotional impacts on adolescents,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. “As an efficacious once-daily pill, we believe that CIBINQO offers an important new treatment option for adolescents burdened by uncontrolled symptoms of atopic dermatitis. Encouraged by an increasing uptake in the adult population, we look forward to bringing this important new oral medicine to adolescents who have yet to find relief from this inflammatory skin condition with current options.”