GSK One Step Closer To FDA Approval For Anemia Drug For Dialysis Patients

The FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 13 to 3 votes in favor of GSK plc's GSK daprodustat for adult dialysis patients with anemia of chronic kidney disease (CKD).
In adult non-dialysis patients with anemia of CKD, the CRDAC did not support that the benefit of treatment with daprodustat outweighs the risks with a 5 to 11 vote.
In April 2022, the FDA accepted the daprodustat marketing application and assigned a Prescription Drug User Fee Act date of 1 February 2023.
CKD affects 700 million patients worldwide, with an estimated one in seven also developing anemia.
Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), was studied in the ASCEND phase 3 trial program, which included five pivotal trials.
All five pivotal trials met the primary endpoints.
In March 2022, the European Medicines Agency validated the marketing authorization application for daprodustat, which is currently under regulatory review, with a regulatory decision anticipated in the first half of 2023.
In June 2020, Japan approved Duvroq (daprodustat) for patients with anemia of CKD.
Price Action: GSK shares are up 0.31% at $32.79 during the premarket session on the last check Thursday.