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

 
• By Sarah Karlin-Smith

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.

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
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