FDA grants priority review and EMA accepts regulatory submission for Pfizer’s abrocitinib

Pfizer announced 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.

“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,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “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.

“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,” said Jonathan Silverberg, MD, PhD, MPH, Department of Dermatology, The George Washington University School of Medicine and Health Sciences. “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.