Pfizer's JAK1 Inhibitor Abrocitinib (Cibinqo) Receives FDA Approval for New Indication in Adolescents with Moderate-to-Severe Atopic Dermatitis

On February 10, Pfizer announced that the FDA had approved the supplemental New Drug Application (sNDA) for its JAK1 inhibitor abrocitinib (brand name: Cibinqo) for the treatment of refractory moderate to severe atopic dermatitis (AD) in adolescents (12 to <18 years old) who have had an inadequate response to or are unsuitable for other systemic treatments.

Atopic dermatitis (commonly known as eczema) is one of the most common chronic inflammatory skin diseases, characterized by skin inflammation and skin barrier defects. Statistics show that 5-10% of adults and approximately 11% of children in the United States are affected by atopic dermatitis. Among them, about one-third of adults and one-third of children and adolescents (1 year old and below) suffer from moderate to severe disease severity.

Abrocitinib is a JAK1 inhibitor independently developed by Pfizer. It was first approved for marketing in Japan in September 2021 for the treatment of moderate to severe atopic dermatitis patients aged 12 years and above. In January 2022, the product received FDA approval for the treatment of adult patients with moderate to severe atopic dermatitis.

The FDA's approval this time is mainly based on positive data from four Phase III studies, including the JADE TEEN study. The JADE TEEN study is a randomized, double-blind, placebo-controlled clinical trial that enrolled a total of 287 patients, aiming to evaluate the efficacy and safety of Abrocitinib (100mg or 200mg, once daily) in adolescents (12 to <18 years old) with moderate to severe atopic dermatitis. The primary endpoints of the study were the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0/1 at week 12 and the proportion of patients achieving a 75% or greater improvement in the Eczema Area and Severity Index (EASI-75 response) at week 75.

Results showed that a higher proportion of patients in the abrocitinib group achieved IGA 0/1 compared to the placebo group (41.6% in the 100mg group vs 46.2% in the 200mg group vs 24.5% in the placebo group; P<0.05), and a greater proportion also achieved EASI-75 response (68.5% in the 100mg group vs 72.0% in the 200mg group vs 41.5% in the placebo group; P<0.05).

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