FDA Expands Cibinqo Label for Atopic Dermatitis in Adolescents

The FDA has approved an additional indication for Pfizer’s Cibinqo (abrocitinib) to include adolescents (12 to <18 years) with refractory, moderate-to-severe atopic dermatitis (AD). It was was previously approved only for the treatment of adults 18 years and older.

Cibinqo is an oral, once-daily, Janus kinase 1 (JAK1) inhibitor. Inhibition of JAK1 is thought to modulate multiple cytokines involved in atopic dermatitis. It has an average retail price of $6,497.80 for 30 tablets, according to GoodRx. Pfizer offers a savings card with as little as $0 out of pocket up to a maximum of $15,000 annually.

Atopic dermatitis is a chronic skin disease characterized by inflammation of the skin and skin barrier defects, and it can cause an abnormal immune response beneath the skin. About one in three adults and one in three children and adolescents, 17 and under, with have moderate-to-severe atopic dermatitis.

Lawrence Eichenfield, M.D.

“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,” Lawrence Eichenfield, M.D., chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital in San Diego, said in a press release.

The prescribing information was updated to include data from JADE TEEN, a phase 3 trial that supported the expanded indication. It evaluated both the 100 mg and 200 mg doses of Cibinqo versus placebo in adolescents 12 to <18 years of age. 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).

In the JADE TEEN trial, the Investigator Global Assessment at week 12 was 39% with Cibinqo 100 mg, 46% with 200 mg, and 24% with placebo. Eczema Area and Severity Index was 64% with the 100 mg dose, 71% with the 200 mg dose and 41% with placebo.

Across trials, the most common adverse events reported included nasopharyngitis, nausea, and headache.