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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