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