AstraZeneca Says US FDA Calls for Extra Clinical Trial on Safety of Roxadustat
August 11 2021 - 10:15AM
Dow Jones News
By Ian Walker
AstraZeneca PLC said Wednesday that the U.S. Food and Drug
Administration has asked for an extra clinical of roxadustat for
the treatment of anemia of chronic kidney disease before it can
approve the company's new drug application.
The pharmaceutical giant said that it is working with its
partner FibroGen Inc. to evaluate the next steps.
AstraZeneca added that the safety and effectiveness of
roxadustat has been demonstrated in a Phase 3 program in more than
8,000 patients.
Roxadustat is already approved in a number of countries,
including China and Japan, and is under regulatory review in the
European Union and other jurisdictions, the company said.
Write to Ian Walker at ian.walker@wsj.com
(END) Dow Jones Newswires
August 11, 2021 10:03 ET (14:03 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
From Mar 2024 to Apr 2024
AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
From Apr 2023 to Apr 2024
