FDA, EMA Accept Regulatory Submission For Pfizer's Abrocitinib For Atopic Dermatitis Treatment

(RTTNews) - Pfizer Inc. (PFE) said that the U.S. Food and Drug Administration accepted for filing and granted priority review designation to the company's New Drug Application for abrocitinib (100mg and 200mg) 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.

abrocitinib is an investigational oral once-daily Janus kinase 1 inhibitor.

The filings were based on the results of a Phase 3 clinical trial on abrocitinib, which demonstrated significant symptom improvement versus placebo as well as a consistent safety profile.

The European Medicines Agency has also accepted the Marketing Authorization Application for abrocitinib in the same patient population with a decision anticipated in the second half of 2021.

According to the company, Abrocitinib has demonstrated strong efficacy at relieving the signs and symptoms of atopic dermatitis, including rapid reduction of itch, across multiple clinical trials.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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