Pfizer's Oral JAK1 Inhibitor Abrocitinib Receives FDA Priority Review for Moderate to Severe Atopic Dermatitis in Patients Aged 12+

Pfizer Announces FDA Acceptance of New Drug Application for Abrocitinib with Priority ReviewPfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for abrocitinib and granted it Priority Review designation. Abrocitinib is a once-daily oral JAK1 inhibitor indicated for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD). The FDA is expected to issue its decision by April next year. Pfizer also announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for abrocitinib in the same patient population, with a decision anticipated in the second half of 2021.

Atopic dermatitis is a chronic, relapsing skin disease characterized primarily by severe pruritus, skin fissuring, and inflammation that can occur on any part of the body. Patients with moderate-to-severe atopic dermatitis may experience skin damage and insomnia due to intense itching. Like other chronic inflammatory diseases, atopic dermatitis is an immune-mediated condition, in which complex interactions between immune cells and inflammatory cytokines play a crucial role in its pathogenesis. As one of the most common forms of chronic dermatitis, it affects up to 20% of children and 10% of adults worldwide. Moreover, approximately half of these pediatric patients experience recurrent symptoms. Therefore, there is a need for novel therapeutics to help them manage their condition.

Abrocitinib is an oral small molecule that selectively inhibits JAK1. Inhibition of JAK1 is believed to modulate multiple cytokines involved in the pathogenesis of atopic dermatitis, including IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP). Previously, abrocitinib was granted Breakthrough Therapy Designation by the U.S. FDA.

▲Molecular structure of abrocitinib (Image source: User:Edgar181, Public domain, via Wikimedia Commons)

This application is based on the positive results from multiple Phase 3 clinical trials, in which abrocitinib demonstrated statistically significant improvements in skin clearance rates and disease severity, as well as rapid relief of pruritus symptoms compared with placebo. For example, in the JADE MONO-1 trial, a randomized, double-blind, placebo-controlled Phase 3 study, 43.8% and 23.7% of patients in the treatment groups achieved an Investigator’s Global Assessment (IGA) score of 0/1 (indicating clear or almost clear skin) after 12 weeks of treatment, compared with 7.9% in the placebo group. Furthermore, 62.7% and 39.7% of patients in the treatment groups achieved at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI 75), versus only 11.8% in the placebo group, thereby meeting the primary efficacy endpoint of the trial.

References:

[1] FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib, an Oral Once-Daily JAK1 Inhibitor, for Patients 12 and Up with Moderate to Severe Atopic Dermatitis. Retrieved October 27, 2020, from https://www.businesswire.com/news/home/20201027005434/en

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