What Negative Roxadustat FDA AdCom Vote Means for Fibrogen's (FGEN) Stock?
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FibroGen Announces Outcome of FDA Advisory Committee Review of Roxadustat for Treatment of Anemia of Chronic Kidney Disease
July 15, 2021 6:26 PM EDTSAN FRANCISCO, July 15, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted to recommend not approving roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, for the treatment of anemia due to chronic kidney disease (CKD) in adult patients. The Committee based its recommendation on data from a global Phase 3 program encompassing more than 8,000 patients. While the FDA is not required to follow the Committee's vote, the agency considers the Committee's non-binding recommendations when making its decision.
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