FDA CRDAC supports benefits of daprodustat in anaemia of chronic kidney disease.- GSK
GSK reports that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) supported that the benefit of treatment with daprodustat outweighs the risks for adult dialysis patients with anaemia of chronic kidney disease (CKD) with a 13 to 3 vote.
In adult non-dialysis patients with anaemia of CKD, the CRDAC did not support that the benefit of treatment with daprodustat outweighs the risks with a 5 to 11 vote.
The FDA will consider the vote, feedback, and recommendations from the CRDAC as it reviews the New Drug Application (NDA) and is not bound by the Committee’s recommendation. The CRDAC provides the US FDA with independent, expert advice and reviews and evaluates available data concerning the safety and efficacy of marketed and potential new medicines for use in the treatment of cardiovascular and renal disorders. In April 2022, the FDA accepted the NDA for daprodustat and assigned a Prescription Drug User Fee Act date of 1 February 2023.
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