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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GSK now looks free to pursue its ‘Plan A’ for the consumer division, but activist investors may push for a new bidder to be found.
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.