Pfizer Gets FDA Priority Review of Abrocitinib in Atopic Dermatitis
October 27 2020 - 7:59AM
Dow Jones News
By Colin Kellaher
Pfizer Inc. on Tuesday said the U.S. Food and Drug
Administration granted priority review to its new drug application
for abrocitinib for the treatment of moderate-to-severe atopic
dermatitis, the most common form of the inflammatory skin disease
eczema, in patients 12 and older.
The New York drugmaker said the FDA is expected to make a
decision in April 2021, adding that the European Medicines Agency
has also accepted its application for abrocitinib in the same
patient population, with a decision expected in the second half of
2021.
The FDA grants priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review
period.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 27, 2020 07:44 ET (11:44 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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