CHMP gives positive opinion recommending authorisation to GSK’s CKD drug
Global biopharmaceutical company GSK has announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has given its drug treatment for symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis a positive recommendation for authorisation.
Daprodustat is a hypoxia-inducible factor‒prolyl hydroxylase inhibitor (HIF-PHI). Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes associated with the correction of anaemia. It was approved by the US Food and Drug Administration in February 2023 for the treatment of anaemia due to CKD in adults who have been receiving dialysis for at least four months.
The positive CHMP opinion was made due to data from three phase 3 global trials ‒ ASCEND-D, ASCEND-ID and ASCEND-DT. The trials assessed the efficacy and safety of daprodustat for the treatment of CKD-associated anaemia compared to standard of care erythropoiesis-stimulating agent (ESA) therapy in adult patients: on dialysis, (ASCEND-D, November 2021); on incident dialysis (ASCEND-ID, April 2022); and three-times weekly dosed on dialysis (ASCEND-TD, September 2022).
CKD, a progressive loss of kidney function, affects roughly 700 million patients worldwide, with an estimated one in seven developing anaemia. This results in an increase in morbidity, mortality and reduced quality of life.
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