Daprodustat belongs to a novel class of oral treatments for CKD-related anemia. Already available for CKD-related anemia in Japan, its uptake has been impressive. In other markets, upon approval, it is expected to differentiate itself from entrenched, injectable erythropoiesis-stimulating agents (ESAs) by its safety profile, efficacy and oral administration. As such, it will help fill the gap in safe treatments for this growing patient population.
Approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan and under review by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), daprodustat is an HIF-PHI developed to treat anemia associated with CKD, which has a high incidence rate and few effective, safe treatment options. The New Drug Application (NDA) submitted to the U.S. FDA was supported by results from the phase 3 ASCEND program, which included five studies investigating daprodustat across the spectrum of CKD:
In 2018, GSK plc and Kyowa Hakko Kirin entered into a strategic collaboration agreement for Kyowa Hakko Kirin to commercialize daprodustat in Japan.
• Marketing authorization application (MAA) validated: European Medicines Agency (EMA)
• NDA accepted: U.S. FDA
February 1, 2023:
• PDUFA date
Actual and expected launch:
• 2020: Japan
• 2023: United States and Europe
Patents estimated to expire beginning in 2027
How will daprodustat impact the market for CKD-related anemia?
What gaps in treatment does daprodustat fill?
Anemia is a common complication of CKD and worsens as kidney disease progresses. Current treatment involves injectable recombinant ESAs, which have associated serious adverse cardiac reactions and risk of sudden cardiac death in addition to inconsistent responses. Daprodustat could potentially be a game changer for these patients, providing a safer option that significantly improves outcomes regardless of dialysis status.
What hurdles might it need to overcome to reach blockbuster status?
Daprodustat will compete with Aranesp®, MIRCERA® and EPOGEN®/PROCRIT®, which currently dominate market sales, in addition to other well-established therapeutic approaches in CKD such as intravenous iron replacement products and blood transfusions that offer rapid increases in hemoglobin levels. In October, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted in favor of the drug’s use in adult dialysis patients, but not in adult non-dialysis patients.
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