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A Mixed AdComm: REMS Seems Possible For GSK’s Anemia Drug, Dual Indication Likely Needs More Data

Executive Summary

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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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. 

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