FibroGen (FGEN) announces FDA will hold an advisory committee meeting to review the new drug application for roxadustat

FibroGen, Inc. (Nasdaq: FGEN) and its partner, AstraZeneca (LSE/STO/Nasdaq: AZN), today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will hold an advisory committee (AdCom) meeting to review the new drug application for roxadustat in the U.S. The companies have not received a confirmed AdCom meeting date from the FDA.

“While disappointed with the news today, FibroGen and AstraZeneca are committed to working with the FDA to bring roxadustat to patients with anemia of CKD in the U.S. as soon as possible,” said Enrique Conterno, Chief Executive Officer, FibroGen. “We continue to be confident in the efficacy and safety profile of this potential new medicine based on positive results from a global Phase 3 program encompassing more than 8,000 patients.”

Roxadustat has been approved in China, Japan and Chile for the treatment of anemia of CKD in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients.

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.

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