FDA Rejects FibroGen's Roxadustat for Anemia of Chronic Kidney Disease

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 [e-mail]

(END) Dow Jones Newswires

August 11, 2021 07:53 ET (11:53 GMT)

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