Category: Anaemia
GlaxoSmithKline says the FDA has started its review of daprodustat for anaemia associated with chronic kidney disease (CKD), as it strives to succeed where two other rivals in the HIF-PHI class have failed. GSK has submitted daprodustat base on its ASCEND phase 3 programme, which included five trials across both dialysis and non-dialysis patients and […]
The EU regulator has approved FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug in the US. The decision makes Evrenzo (roxadustat) the first oral HIF-PH inhibitor to be cleared for use in the EU, ahead of rival candidates daprodustat from […]
Shots: The P-III ASCEND program includes 5 studies i.e ASCEND-ND, D, ID, NHQ & TD studies evaluating efficacy & safety of daprodustat vs ESA in ~8,000 patients with anemia due to CKD for ~ 3.75yrs. The program met its 1EPs in 5 studies i.e improvement in Hgb levels in untreated patients and maintaining Hgb levels […]