GSK: FDA Advisory Committee Supports Daprodustat Use In Adult Dialysis Patients With Anaemia Of CKD

GSK plc (GSK,GSK.L) Thursday announced that the US Food and Drug Administration’s Advisory Committee has supported the use of daprodustat in adult dialysis patients with anaemia of chronic kidney disease or CKD, but not in adult non-dialysis patients with anaemia of CKD.

In a statement, the company said the Cardiovascular and Renal Drugs Advisory Committee or CRDAC, with a 13 to 3 vote, supported that the benefit of treatment with daprodustat outweighs the risks for adult dialysis patients.

Meanwhile, the committee, with a 5 to 11 vote, did not support that the benefit of treatment with daprodustat outweighs the risks in adult non-dialysis patients.

The FDA, which has accepted the New Drug Application or NDA for daprodustat in April 2022, will consider the vote, feedback, and recommendations from the CRDAC as it reviews the NDA, but is not bound by the Committee’s recommendation.

The FDA assigned a Prescription Drug User Fee Act date of February 1, 2023.

Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). The ASCEND phase III clinical trial programme included five pivotal trials assessing the efficacy and safety of daprodustat for the treatment of anaemia across the spectrum of CKD, ad all five pivotal trials met the primary endpoints.

In March 2022, the European Medicines Agency validated the marketing authorisation application for daprodustat, which is currently under regulatory review, with a regulatory decision anticipated in the first half of 2023.

In June 2020, Duvroq (daprodustat) tablets were approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of patients with anaemia of CKD.

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