Expert Interview
Discussing GSK’s Daprodustat in Chronic kidney disease, ahead of the PDUFA date of 2/1/2023
Ticker(s): GSKInstitution: Indiana University
- Professor of Clinical Medicine at Indiana University School of Medicine in Indianapolis and Chief Medical Officer for Outpatient Dialysis at Indiana University Health.
- Treats 30 dialysis patients with anemia and around 200 non-dialysis CKD patients with anemia.
- Has served as an advisor to the Centers for Medicare and Medicaid Services (CMS) on quality improvement issues in dialysis and has published over 100 articles, reviews, and book chapters.
Please describe your practice as a clinician, how many patients with CKD do you see on a yearly basis? Can you describe the standard of care, and take us through the most promising upcoming treatments, or interesting clinical trials in this space?
How much of an unmet need is there in CKD, and how important is resolving anemia in CKD patients in improving patient outcomes? How would you judge the mechanism of action, the Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilizing hypoxia-inducible factors, leading to transcription of erythropoietin and other genes involved in the correction of anemia. Where do you see the risks-benefits in this approach?
Could you please comment on the ad-com vote results from Oct 22, with 13 to 3 vote that benefits of treatment do outweigh risks in dialysis patients & 5 to 11 vote that benefits do not outweigh risks in non-dialysis patients?
What are your high level thoughts in regards to thrombosis, cardiovascular events,hypertension, cancer risks, improvements in hepcidin levels and efficacy in patients with elevated EPO levels treated with HIF inhibitors?
Is it fair to conclude that daprodustat did not increase VA thrombosis in ASCEND-D (Hazard Ratio 0.80, 95% CI 0.65-0.98), and in ASCEND-ND trials? ( HR 1.49 (0.94 - 2.35).)
Would you use dapradustat in patients on dialysis, if approved? Under what circumstances would it make sense to use it in CKD patients, considering the balance of risk-reward?
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