PF 04965842 filed with MAA and FDA for atopic dermatitis.- Pfizer

Pfizer Inc. announced that the FDA accepted for filing and granted Priority Review designation to the company’s New Drug Application (NDA) for PF 04965842 (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 a robust Phase III 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. In particular 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.