AstraZeneca Says US FDA Advisory Committee Has Voted Against Approval of Roxadustat
July 16 2021 - 2:40AM
Dow Jones News
By Ian Walker
AstraZeneca PLC said Friday that the U.S. Food and Drug
Administration's Cardiovascular and Renal Drugs Advisory Committee
has voted against the approval of a new drug application for
roxadustat, a treatment for anemia of chronic kidney disease.
The pharmaceutical company said the committee voted 13-to-one
against the benefit-risk profile of roxadustat in non-dialysis
dependent adult patients, and 12-to-two against roxadustat in
dialysis-dependent adult patients.
The FDA said it will consider the vote, independent opinions and
recommendations from experts as it reviews the new drug
application, and that it isn't bound by the committee's
recommendation.
Write to Ian Walker at ian.walker@wsj.com
(END) Dow Jones Newswires
July 16, 2021 02:36 ET (06:36 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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