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FibroGen announces outcome of FDA Advisory Committee review of roxadustat.

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Published:16th Jul 2021
FibroGen, Inc. announced that the 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 III 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.

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.

"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.”

Condition: Anaemia and CKD
Type: drug

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