AstraZeneca: FDA Requests More Analysis for Approval of Roxadustat
December 21 2020 - 2:44AM
Dow Jones News
By Sabela Ojea
AstraZeneca PLC said Monday that the U.S. Food and Drug
Administration has requested further analysis of clinical data of
its Roxadustat drug to complete the review of the new drug
application.
The British-Swedish pharmaceutical giant said it will submit
along with FibroGen, Inc. additional data to assist with the
completion of labeling discussions.
The FTSE-100 listed company added that the new drug application
is still under regulatory view, noting that the FDA has set a new
action date of March 20, 2021.
The Roxadustat-drug is an oral inhibitor for patients with
anemia of chronic kidney disease.
Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix
(END) Dow Jones Newswires
December 21, 2020 02:29 ET (07:29 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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