A Mixed AdComm: REMS Seems Possible For GSK’s Anemia Drug, Dual Indication Likely Needs More Data
Daprodustat gets a thumbs up from a US FDA advisory committee on one of two proposed indications, but panelists indicate preference for strong pharmacovigilance program for GSK’s oral anemia treatment for chronic kidney disease patients.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
GSK is abandoning one of its new drug prospects after it failed in hard-to-treat rheumatoid arthritis patients at Phase III, raising the stakes for more key readouts due shortly.
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.