GSK Pulls EU Filing For Jesduvroq In CKD Anemia After Label Narrowed

 
• By Eliza Slawther
  
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GSK’s Jesduvroq was set for imminent EU approval to treat anemia in patients with chronic kidney disease receiving dialysis, but the firm has withdrawn its marketing authorization application after the EMA recommended excluding non-dialysis patients from the label.

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Last month, the European Medicines Agency’s scientific advisory panel, the Committee for Medicinal Products for Human Use (CHMP), issued a positive recommendation for the marketing authorization of GSK plc’s oral drug candidate Jesduvroq (daprodustat) to treat adults with symptomatic anemia with chronic kidney disease (CKD) on dialysis. (Also see "EU CHMP Opinions And MAA Updates" - Pink Sheet, 26 June, 2023.).

Yet before Jesduvroq was granted approval from the European Commission, which usually occurs within 67 days of the CHMP adopting...

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