FDA Rejects FibroGen's Roxadustat for Anemia of Chronic Kidney Disease
11 Agosto 2021 - 1:54PM
Dow Jones News
By Colin Kellaher
FibroGen Inc. on Wednesday said the U.S. Food and Drug
Administration has rejected its new-drug application for roxadustat
for the treatment of anemia of chronic kidney disease, with the
agency calling for a new study.
The San Francisco biopharmaceutical company, which is developing
roxadustat with AstraZeneca PLC and Astellas Pharma Inc., said the
FDA issued a complete response letter, indicating that it won't
approve the application in its current form.
FibroGen said that it is "deeply disappointed" with the FDA's
decision, adding that it plans to discuss its next U.S. steps with
AstraZeneca.
FibroGen shares tumbled in mid-July after an FDA advisory
committee recommended that the agency reject the drug, which is
approved in China, Japan, Chile and South Korea.
The European Medicines Agency's Committee for Medicinal Products
for Human Use has recommended approval of the drug, with a final
decision by the European Commission expected by the end of the
month.
Trading in shares of FibroGen, which closed Tuesday at $13.19,
was halted premarket on Wednesday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 11, 2021 07:53 ET (11:53 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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