FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib

Pfizer announced today that 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.

Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development Said: “Atopic dermatitis is a serious, unpredictable, and often debilitating condition that can have a significant impact on the daily lives of patients and their families, We are grateful to those who participated in our clinical studies supporting these regulatory filings and proud that the FDA has granted abrocitinib both Breakthrough Therapy and Priority Review designations. We are working diligently with the regulatory authorities to bring abrocitinib to patients in the U.S. and the EU, where, if approved, it may provide an effective and convenient new option.”

The filings were based on the results of a robust Phase 3 clinical trial program, across which 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. Findings from the following studies in the abrocitinib JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program were included in the submissions:

  • JADE MONO-1 and JADE MONO-2: A pair of studies designed to evaluate the efficacy and safety of two doses (100mg and 200mg once daily) of abrocitinib monotherapy compared to placebo.
  • JADE COMPARE: 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.

Jonathan Silverberg, MD, PhD, MPH, Department of Dermatology, The George Washington University School of Medicine and Health Sciences Said: “Many patients with moderate to severe atopic dermatitis have poorly controlled disease. They need additional treatment options that alleviate the symptoms most important to them, Abrocitinib has demonstrated strong efficacy at relieving the signs and symptoms of atopic dermatitis, including rapid reduction of itch, across multiple clinical trials. If abrocitinib is approved, it could make a meaningful difference in real-world clinical practice.”

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.

Pfizer recently announced results from the fourth trial in the JADE global development program, JADE TEEN. Additional data from other studies in the JADE program will be presented and published in the coming months.

About Abrocitinib

Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. 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.

About Pfizer’s Immunokinase Inhibitor Leadership

The JAK pathways are believed to play an important role in inflammatory processes as they are involved in signaling for over 50 cytokines and growth factors, many of which drive immune-mediated conditions. JAK inhibition may offer patients with these conditions a potential new advanced treatment option.

Pfizer’s leading JAK biology and chemistry expertise, combined with our research experience, has uniquely enabled the company to take a different R&D approach to that of other companies involved in JAK research, resulting in one of the broadest immunokinase inhibitor pipelines. Instead of studying a single molecule for all its potential uses, where it may not be optimal for some, Pfizer’s candidates with unique selectivity profiles are purposefully matched to the conditions where we believe they have the greatest potential to, if approved, address unmet need. Pfizer has five unique immunokinase inhibitors in late-stage clinical trials for the potential treatment of ten immune-mediated diseases:

  • Abrocitinib: A JAK1 inhibitor currently under regulatory review by the FDA and EMA for the potential treatment of moderate-to-severe AD among adolescents and adults
  • Ritlecitinib (PF-06651600): An oral, JAK3/TEC family kinase inhibitor in a phase 3 clinical trial for the potential treatment of alopecia areata (AA) and in phase 2 for vitiligo, Crohn’s disease (CD), and ulcerative colitis (UC)
  • Brepocitinib (PF-06700841): A tyrosine kinase 2(TYK2)/JAK1 inhibitor in phase 2 clinical trials for the potential treatment of psoriasis and AD in topical formulation, and, in oral formulation for psoriatic arthritis, CD, UC, vitiligo, systemic lupus erythematosus (SLE), AA and hidradenitis suppurativa (HS)
  • PF-06826647: A TYK2 inhibitor under investigation in phase 2 clinical trials for the potential treatment of psoriasis and HS
  • PF-06650833: An IL-1 receptor associated kinase 4 (IRAK4) inhibitor under investigation for the potential treatment of rheumatoid arthritis and HS in phase 2 clinical trials

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