Pfizer announced the U.S. Food and Drug Administration (FDA) accepted for filing and granted Priority Review designation to the company’s New Drug Application (NDA) for abrocitinib (100mg and 200mg), an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in patients 12 and older. The FDA is expected to make a decision in April 2021. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for abrocitinib in the same patient population with a decision anticipated in the second half of 2021.
The filings were based on the results of the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program, which included JADE MONO-1, JADE MONO-2 and JADE COMPARE. Across all studies, abrocitinib demonstrated statistically superior improvements in skin clearance, disease extent, and severity, as well as rapid improvements (measured as early as Week 2) in itch versus placebo. Abrocitinib also demonstrated a consistent safety profile across trials and was generally well-tolerated.
JADE MONO-1 and JADE MONO-2 were designed to evaluate the efficacy and safety of two doses (100mg and 200mg once daily) of abrocitinib monotherapy compared to placebo. Data from JADE MONO 1 were reported in October of 2019 and data from JADE MONO 2 were reported in June of 2020.
JADE COMPARE was designed to evaluate the efficacy and safety of two doses (100mg and 200mg once daily) of abrocitinib compared to placebo in patients on background topical therapy. The study also included an active control arm, dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo. Data from JADE COMPARE were reported in March of 2020.
Priority Review designation is granted to medicines that the FDA considers to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious condition. Abrocitinib received Breakthrough Therapy designation from the FDA for the treatment of patients with moderate to severe AD in February 2018. Abrocitinib also received a Promising Innovative Medicine (PIM) designation from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) earlier this year, which indicates that a product may be eligible for the early access to medicines scheme (EAMS) based on early clinical data. EAMS aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization when there is a clear unmet medical need.
Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK). Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of atopic dermatitis, including interleukin (IL)-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).
About Atopic Dermatitis
AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. Lesions of AD are characterized by erythema (skin turning red or purple depending on normal skin color), itching, induration (hardening)/papulation (formulation of papules), and oozing/crusting. AD is one of the most common, chronic, relapsing childhood dermatoses, affecting up to 10% of adults and up to 20% of children worldwide.