BRIEF—Pfizer's abrocitinib closer to US and EU markets for eczema

US pharma giant Pfizer has announced that the US Food and Drug Administration (FDA) has accepted for filing and granted Priority Review designation to its New Drug Application (NDA) for abrocitinib, an 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.

These filings were based on the results of a Phase III trial program, across which abrocitinib demonstrated statistically superior improvements in skin clearance, disease extent, and severity, as well as rapid improvements in itch, versus placebo. Abrocitinib also demonstrated a consistent safety profile across trials and was generally well-tolerated.