Genentech's Esbriet Gets FDA Priority Review in Unclassifiable Interstitial Lung Disease
By Colin Kellaher
Roche Holding AG's Genentech unit on Thursday said the U.S. Food
and Drug Administration granted priority review to the expanded use
of Esbriet for the treatment of unclassifiable interstitial lung
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.
Genentech said the agency is expected to make a decision on its
application by May.
Interstitial lung disease describes a group of more than 200
types of rare pulmonary diseases, each having different causes,
treatment approaches and outlooks, Genentech said, adding that
roughly 10% of patients can't be given a definitive diagnosis and
are categorized as having unclassifiable interstitial lung
The FDA approved Esbriet in 2014 to treat the lung disease
idiopathic pulmonary fibrosis.
Write to Colin Kellaher at email@example.com
(END) Dow Jones Newswires
January 21, 2021 06:54 ET (11:54 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.