Pfizer's JAK1 Inhibitor Abrocitinib Receives Priority Review Designation in China for Adolescents with Moderate-to-Severe Atopic Dermatitis

On September 19, the CDE website showed that a new indication for Pfizer's JAK1 inhibitor abrocitinib is proposed to be included in the priority review, applicable to adolescent patients aged 12 years and above with refractory, moderate to severe atopic dermatitis who have had an inadequate response or are unsuitable for other systemic treatments (such as hormones or biologics).

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.

Abrocitinib is a JAK1 inhibitor independently developed by Pfizer. The product was approved by the FDA and NMPA in January and April 2022, respectively, for the treatment of adult patients with moderate to severe atopic dermatitis.

According to the PharmaCube database, a Phase III clinical trial (CTR20190674) registered in China for abrocitinib in patients aged 12 to <18 with moderate to severe atopic dermatitis was completed on June 29, 2021. The study aimed to evaluate the efficacy and safety of abrocitinib in combination with background topical medications for treating adolescent patients aged 12 to <18 with moderate to severe atopic dermatitis who had an inadequate response to or were unsuitable for topical treatment.

Another Phase III study (CTR20181767) registered in China, evaluating abrocitinib monotherapy for adolescent and adult patients aged 12 years and older with moderate to severe atopic dermatitis, was also completed on February 28, 2020.

In February this year, Abrocitinib received FDA approval for a new extended indication to treat atopic dermatitis in adolescents (12 to <18 years old). The FDA's approval was primarily 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 287 patients, aiming to evaluate the efficacy and safety of abrocitinib (100mg or 200mg, once daily) in adolescents (ages 12 to <18 years) 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 at least a 75% improvement in the Eczema Area and Severity Index (EASI-75 response) by week 75.

Results showed that, compared with the placebo group, a higher proportion of patients in the abrocitinib group achieved IGA 0/1 (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 of patients 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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