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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The company announced positive Phase II data for roxadustat in chemotherapy-induced anemia.
The US FDA advisory committee review of AstraZeneca/FibroGen’s roxadustat for anemia was the last in the long tenure of Office of Cardiology Director Ellis Unger. His opening remarks struck a valedictory tone.
Keeping Track: Merck & Co. In Spotlight With Welireg, Keytruda Approvals; FibroGen/AZ Roxadustat CRL Is No Surprise
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.