Posted by Michael Wonder on 26 Jun 2023
GSK receives positive CHMP opinion recommending authorisation of daprodustat for symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis
26 June 2023 - GSK today announced that the CHMP of the EMA has issued a positive opinion recommending authorisation of daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, for the treatment of symptomatic anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis.
The positive CHMP opinion is based on data from three global Phase III trials in dialysis patients from the ASCEND clinical trial programme, including ASCEND-D, which is a non-inferiority trial that assessed the efficacy and safety of daprodustat for the treatment of anaemia of chronic kidney disease in adult patients on dialysis with a comparator of a standard of care erythropoiesis-stimulating agent therapy.
