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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The UK major’s Jesduvroq has become the first drug of its class to win US approval for anemic kidney disease but significant label restrictions have left some analysts lukewarm on its sales potential.
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.