Good News At Last For GSK With Daprodustat, But Safety Scrutiny Awaits
Likely To Dominate US Market If Approved
GSK could gain a first-in-class approval for anemia in chronic kidney disease in the US, but approval and uptake of the HIF inhibitor in non-dialysis patients remain uncertain.
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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.
GSK achieved a first-in-class market oncology launch in 2020, but will have to increase that hit rate in order to fulfil its blockbuster ambitions.
Phil Dormitzer has been headhunted to help GSK get up to speed in RNA and other vaccine platforms.