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FibroGen (FGEN) Says FDA Advisory Committee Voted to Recommend Not Approving Roxadustat

July 15, 2021 6:34 PM EDT

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.

“While we are disappointed with today's outcome,” said Enrique Conterno, Chief Executive Officer, FibroGen, “we believe the scientific evidence supports roxadustat approval in the U.S. and will work with the FDA as it completes its review of the New Drug Application for roxadustat.”

Roxadustat is approved in China, Japan, Chile, and South Korea for the treatment of anemia of CKD in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) adult patients and has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s committee responsible for human medicines. Roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is the first HIF-PH inhibitor accepted by the FDA for review for the treatment of anemia of CKD. Roxadustat has the potential to transform treatment for anemia of CKD.

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.2



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