FDA highlights safety questions ahead of AdComm meeting for GSK anemia drug

Oct. 26, 2022

An FDA advisory panel will meet today to discuss GSK's NDA for its oral anemia drug — and the agency has highlighted its concerns in a briefing doc.

The Cardiovascular and Renal Drugs Advisory Committee will discuss GSK's daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) under regulatory review for the potential treatment of anaemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis.

If approved, daprodustat — which has a PDUFA date of Feb. 1, 2023 — would be the first orally available treatment for anemia of CKD and the first marketed HIF prolyl hydroxylase inhibitor.

But the FDA wants to make sure its advisory panel takes a close look at safety.

The oral route of daprodustat provides some convenience over the parenteral erythropoietin stimulating agents (ESAs) — the standard of care — but it also comes with "potential downsides," said the FDA in its briefing doc. These include risks of inadequate hemoglobin  monitoring in some settings, which might lead to worse outcomes.

The agency specifically wanted to call attention to the use of daprodustat in the non-dialysis-dependent population,  where it appears to elevated the estimated hazard ratios for major adverse cardiac events. According to the agency, it "noted elevated estimated hazard ratios for cardiovascular mortality, myocardial infarction, stroke, thromboembolic disease, and vascular access thrombosis. 

GSK is confident in its trial data and says it is committed to working with the agency on the drug's approval.