Expert Interview
Discussing Akebia’s Vadadustat for the treatment of anemia due to chronic kidney disease (CKD), ahead of the PDUFA date: March 29, 2022
Ticker(s): AKBAInstitution: Columbia Nephrology
- Nephrologist in private practice in South Carolina with over 10 years of experience; MS in Cytopathology
- Treats 200 patients with CKD and familiar with GIF inhibitors and the INNO2VATE Global Phase 3 trial of Vadadustat
- Medical Director of Clinical Research and interests include hypertesion and glomerular diseases.
Please describe your clinical practice. How many patients with chronic kidney disease do you currently manage? What is the most common symptom in your patients, and what percent of your patients have anemia?
What percent of patients are on dialysis-dependent injectable ESAs? How much of a need is there for Vadadustat?
Added By: catalin_adminCan you tell us more about the mechanism of action of hypoxia-inducible factor prolylhydroxylase (HIF-PH) inhibitors, and how they compare?
In INNO2VATE Phase 3 trial, vadadustat was shown to be noninferior to darbepoetin alfa with respect to cardiovascular safety (major adverse cardiovascular events [MACE]) and hematologic efficacy. Could you please discuss this comparison?
In the PEARL (Peginesatide for the Correction of Anemia in Patients with Chronic Renal Failure Not on Dialysis and Not Receiving Treatment with Erythropoiesis-Stimulating Agents) trials, which involved patients with NDD-CKD, peginesatide did not meet its noninferiority margin for safety as compared with darbepoetin alfa (hazard ratio, 1.32; 95% CI, 0.97 to 1.81).17 The reasons for these discrepant results among patients with DD-CKD and those with NDD-CKD remain unclear. What lessons can be drawn from this?
Added By: catalin_adminHow important are the company’s main selling points of the drug, in your opinion:-Minimizing hemoglobin in predictable, controlled manner -Minimizing hemoglobin overshoots -Maintaining EPO within physiologic range -Fewer dose adjustments than ESA comparato
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