Pfizer Submits New Indication Application in China for JAK1 Inhibitor Abrocitinib to Treat Adolescents with Moderate-to-Severe Atopic Dermatitis

On July 14, the CDE website showed that the new indication application for Pfizer's JAK1 inhibitor abrocitinib was accepted. It is speculated that the indication submitted for marketing approval this time is for the treatment of refractory moderate to severe atopic dermatitis in adolescents (12 to <18 years old) who have had an inadequate response or are unsuitable for other systemic treatments.

Atopic Dermatitis (Commonly Known as Eczema) is the most common type of chronic inflammatory skin disease, characterized by skin inflammation and skin barrier defects. According to statistics, 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) for abrocitinib registered in China for 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 combined with background topical medications in treating adolescent patients aged 12 to <18 with moderate to severe atopic dermatitis who had an inadequate response to or were unsuitable for topical treatments.

Another Phase III study (CTR20181767) registered in China, investigating the monotherapy of abrocitinib in 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 an expanded new 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. It aims to evaluate the efficacy and safety of abrocitinib (100mg or 200mg, once daily) in adolescent patients (aged 12 to <18 years) with moderate to severe atopic dermatitis. The primary endpoints of the study are 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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