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FibroGen Plunges As FDA Panel Rejects Drug For Anemia Linked To Kidney Disease By

By Dhirendra Tripathi – FibroGen (NASDAQ:) stock slumped 44% Friday as an advisory committee of the Food and Drug Administration rejected the company’s proposed inhibitor to treat anemia in adult patients suffering from chronic kidney disease.

While the Committee’s vote is not binding on the FDA, the agency considers its recommendations when making its decision.

FibroGen’s roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor, is approved in China, Japan, Chile, and South Korea for the treatment of anemia of CKD in both non-dialysis-dependent and dialysis-dependent adult patients.

Anemia of CKD is a condition in which people have insufficient red blood cells, which reduces oxygen delivery throughout the body.1 Anemia becomes increasingly common among patients with CKD as the disease progresses whether or not they are on dialysis.

FibroGen is collaborating with AstraZeneca on the development and commercialization of roxadustat for the potential treatment of anemia of CKD in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

AstraZeneca (NASDAQ:) stock was unaffected by the news and traded up nearly 1%.

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