Keep up with the latest updates on past Molecules of the Month! From a Ph. III oral HIF-PH inhibitor receiving a favorable response from the EMA to an oral mutant IDH1/2 inhibitor with FIC potential having favorable Ph. III results for hard-to-treat brain tumors, read more about the recent updates in the full article!
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Akebia Therapeutics’ vadadustat, a Sept. 2022 Molecule of the Month, is set to be approved in Europe to treat dialysis-dependent anemia in chronic kidney disease following a positive opinion from the European Medicines Agency (EMA). The oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI) increases erythropoietin production to increase levels of red blood cells. The EMA opinion was based on the INNO2VATE trials, which showed that vadadustat (QD) was non-inferior to darbepoetin alfa (Arenesp, recombinant human erythropoietin; i.v. or s.c.), as measured by the mean change in hemoglobin levels and major adverse cardiovascular events (NCT02865850, NCT02892149). Meanwhile, safety concerns about thromboembolic effects in non-dialysis patients are hampering the drug’s FDA approval.
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