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FibroGen’s Roxadustat Rejected By US FDA Panel Due To Safety Concerns, Untested Dosing Strategy

 
• By Sue Sutter

But advisory committee members see a potential opportunity for the oral anemia drug in small percentage of dialysis-dependent patients not responsive to erythropoiesis-stimulating agents; FibroGen’s revised dosing algorithm, aimed at slowing hemoglobin rate of increase and reducing risk of thrombosis, needs to be clinically tested before marketing approval, panelists said.

Bumpy road
Roxadustat's bumpy road in the US just got bumpier with a negative adcomm review. • Source: Alamy

A US Food and Drug Administration panel on 15 July overwhelmingly recommended against FibroGen, Inc.’s anemia drug roxadustat for two separate populations of chronic kidney disease patients, citing safety concerns and the need to test the sponsor’s proposal for a new dosing algorithm prior to approval.

The Cardiovascular and Renal Drugs Advisory Committee acknowledged the potential convenience offered by an oral treatment for anemia as well as roxadustat’s efficacy in boosting hemoglobin for CKD patients on dialysis as well as those not on dialysis

Advisory Committee Votes

  • Should roxadustat be approved for the treatment of anemia due to chronic kidney disease in adult patients not on dialysis

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