U.S. FDA declines to approve FibroGen's anemia drug

[August 11, 2021]  (Reuters) -FibroGen Inc said said on Wednesday that the U.S. Food and Drug Administration has declined to approve its treatment for anemia of chronic kidney disease, citing the need for an additional clinical study.

Last month, a panel of experts to the FDA voted against the approval of the company's drug candidate, roxadustat, which the company is developing in partnership with AstraZeneca.

Ahead of the expert panel meeting, the FDA had raised concerns about safety and efficacy of the drug, which is already approved in China, Japan, Chile, and South Korea.

The company said the letter from the regulator indicates that it will not approve the roxadustat's marketing application in its present form and has requested additional clinical study of roxadustat.

(Reporting by Manas Mishra and Dania Nadeem in Bengaluru; Editing by Arun Koyyur)

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