CHMP positive for Jesduvroq to treat symptomatic anemia in adults with chronic kidney disease who are on dialysis – GSK

Jesduvroq (daprodustat) from GSK received a positive opinion from the CHMP for the treatment of adult patients for for the treatment of symptomatic anaemia in adults with chronic kidney disease who are on chronic dialysis. The benefit of Jesduvroq is its ability to correct haemoglobin levels in dialysis-dependent patients, with effects comparable to those seen with erythropoiesis-stimulating agents. The most […]

European Commission approves Evrenzoto treat adult patients with symptomatic anemia associated with chronic kidney disease – Astellas + FibroGen Inc.

Astellas Pharma Inc.and FibroGen, Inc. announced that the European Commission (EC) has approved Evrenzo (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney diseases (CKD). CKD impacts one in 10 people globally, of whom one in five are affected by anemia. Anemia of CKD is often untreated or not treated to target, and is associated […]

GSK announces positive headline results from five phase III studies of daprodustat for patients with anaemia due to chronic kidney disease

GlaxoSmithKline plc announced positive headline results from five studies of the Phase III ASCEND programme, evaluating the efficacy and safety profile of daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for patients with anaemia due to chronic kidney disease (CKD). The ASCEND programme showed that daprodustat met its primary efficacy endpoint in each study, demonstrating an improvement in […]

FibroGen provides additional information on roxadustat to the FDA relating to U.S. primary cardiovascular safety analyses

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