FDA Expands Label for Abrocitinib to Include Adolescents With Atopic Dermatitis

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The treatment, developed by Pfizer, has been approved by the FDA for adult patients with atopic dermatitis.

The US Food and Drug Administration (FDA) has approved abrocitinib (CIBINQO) for the treatment of adolescent patients 12-18 years with refractory, moderate-to-severe atopic dermatitis, whose disease is not adequately controlled with other systemic treatments, including biologics, or when use of those therapies is inadvisable.

The treatment, developed by Pfizer, was previously approved for adult patients with atopic dermatitis. The treatments prescribing information now includes data from a phase 3 randomized, placebo-controlled trial called JADE TEEN.

In the study, the investigators evaluated both 100 mg and 200 mg abrocitinib compared to placebo for 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).

The IGA 0 or 1 Response Rate at week 12 was 39% with abrocitinib 100 mg, 46% with abrocitinib 200 mg, and 24% with placebo, while the EASI-75 Response Rate at week 12 was 64%, 71%, and 41%, respectively.

For safety, nasopharyngitis (12.4% with abrocitinib 100 mg, 8.7% with abrocitinib 200 mg, and 7.9% with placebo), nausea (6%, 14.5%, and 2.1%, respectively), and headache (6%, 7.8%, and 3.5%, respectively) were the most common adverse events.

“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, in a statement. “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.”