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

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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

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Aug 11 (Reuters) - FibroGen Inc said (FGEN.O) 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 (AZN.L).

FibroGen shares slipped 2.5% to $12.9 before the bell following the negative decision by the regulator.

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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.

Anemia is a condition in which the number of red blood cells, or hemoglobin concentration within them, is lower than normal, and can commonly affect patients with kidney disease.

Last month, a rival drug, daprodustat, developed by GSK (GSK.L) succeeded in late-stage trials, showing improved hemoglobin levels in patients who had not received any standard care and helped maintain the levels in those who did. read more

Roxadustat is the first of a new kind of oral anemia treatment that boosts production of red blood cells by mimicking the body's response to high altitude.

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.

Difei Yang analyst at Mizuho Securities said commercial performance in China and the drug's scope for growth in Europe, where the drug is expected to be approved later this month, are likely to be the primary short-term catalysts for shares.

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

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