USA – FibroGen Inc said has announced 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.

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

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.

According to WHO, globally, anemia affects 1.62 billion people, which corresponds to 24.8% of the population. The highest prevalence is in preschool-age children, and the lowest prevalence is in men.

A report by Zion market research shows the global anemia treatment market was valued at US$24,673 million in 2018 and is expected to generate around US$40,915 million by 2025, growing at a CAGR of around 7.5% between 2019 and 2025.

Last month, a rival drug, daprodustat, developed by GSK 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.

GSK said studies showed also that daprodustat did not increase the risk of potentially deadly cardiovascular complications like heart attacks and strokes compared to standard treatment for anemia associated with kidney disease.

Daprodustat, approved only in Japan for use in patients with renal anemia, was also well-tolerated in both dialysis and non-dialysis patients, GSK said.

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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