GSK withdrew its EU marketing authorization application for Jesduvroq (daprodustat) earlier this month after the European Medicines Agency’s scientific advisory panel, the CHMP, said the candidate should only be approved in adult patients with anemia resulting from chronic kidney disease (CKD) who are already receiving dialysis.
Safety Concerns Prevented EU Approval For GSK’s Jesduvroq In Non-Dialysis CKD Patients
The European Medicines Agency recommended against the approval of GSK’s Jesduvroq in patients with CKD-related anemia who are not on dialysis because of concerns around its safety profile in these patients.
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