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FDA Says Safety Concerns May Negate Any Oral Dosing Advantage For GSK’s Anemia Treatment

 
• By Sarah Karlin-Smith

When a drug’s biggest advantage becomes its potential downfall: The agency worries that chronic kidney disease patients not receiving dialysis may have worse outcomes on GSK’s anemia treatment daprodustat compared to ESA because of less patient safety monitoring as a result of the drug’s oral administration. 

illustration of anemia
Safety concerns will dominate GSK advisory panel for oral anemia treatment for chronic kidney disease • Source: Shutterstock

The US Food and Drug Administration sees little benefit from the oral administration of GSK plc’s daprodustat for treatment of anemia in chronic kidney disease (CKD) patients, an assessment that may impact the approvability of the drug in the non-dialysis population and its uptake in the dialysis population.

GSK is hoping to be the first to get an oral hypoxia-inducible factor prolyl hydroxylas inhibitor approved for anemia for CKD in the US after FDA issued complete response letters to two competitors over safety concerns

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