The advisory committee experts, however, voted 11 to five against the use of daprodustat in non-dialysis patients with anaemia of CKD, citing increased safety risks such as heart failure and bleeding gastric erosions.
The FDA will consider the vote, feedback and recommendations from the CRDAC as it reviews the New Drug Application for daprodustat, with a final decision expected by 1 February 2023.
CKD, characterised by progressive loss of kidney function, is an increasing global public health burden affecting 700 million patients worldwide, with an estimated one in seven patients also developing anaemia.
