Posted by Michael Wonder on 27 Oct 2020
FDA grants priority review and EMA accepts regulatory submission for Pfizer's abrocitinib, an oral once daily JAK1 inhibitor, for patients 12 and up with moderate to severe atopic dermatitis
27 October 2020 - Filings based on robust abrocitinib clinical trial data demonstrating significant symptom improvement versus placebo as well as a consistent safety profile.
Pfizer announced today that the U.S. FDA accepted for filing and granted priority review designation to the company’s new drug application for abrocitinib (100 mg and 200 mg), an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis in patients 12 and older. The FDA is expected to make a decision in April 2021.
The EMA has also accepted the marketing authorisation application for abrocitinib in the same patient population with a decision anticipated in the second half of 2021.
