Label Woes For GSK’s Jesduvroq Dampen US Anemic Kidney Disease Approval
The UK major’s Jesduvroq has become the first drug of its class to win US approval for anemic kidney disease but significant label restrictions have left some analysts lukewarm on its sales potential.
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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.
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for imminent EU approval to treat anemia in patients with chronic kidney disease receiving dialysis, but the firm has withdrawn its marketing authorization application after the EMA recommended excluding non-dialysis patients from the label.
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