GSK’s Jesduvroq (daprodustat) Receives the US FDA’s Approval for the Treatment of Anaemia
- The US FDA has approved Jesduvroq, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor as 1st oral treatment of anaemia due to CKD undergoing dialysis
- The approval was based on the P-III (ASCEND-D) trial results evaluating Jesduvroq vs recombinant human erythropoietin in 2964 dialysis patients who were switched to receive daprodustat ESA control from an SoC ESA therapy
- The results showed that daprodustat was non-inferior to ESAs regarding the change in the Hb level from baseline & CV outcomes, the major adverse cardiovascular event (25.2% vs 26.7%) during a median follow-up of 2.5yrs., patients with other AEs were similar in 2 groups, mean change in Hb level from baseline to 28-52wks. The MAA for daprodustat is under EMA’s review with a regulatory decision expected in H1’23
Ref: GSK | Image: GSK
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