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.

GSK building — GSK’s Daprodustat Went 1 for 2 At Its 26 October US FDA Advisory Committee Meeting • Source: Shutterstock

GSK plc’s oral anemia drug for chronic kidney disease failed to nab US Food and Drug Administration advisors’ endorsement for one of its two proposed indications at a 26 October advisory committee due to safety concerns.

Advisors also signaled they would also want tight control of the drug’s use in its other indication to optimize safety.