GSK1278863

Daprodustat

Duvroq

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.

About daprodustat

  1. GlaxoSmithKline plc.
  2. Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
  3. Oral administration to treat CKD-related anemia, regardless of dialysis status
  4. ~67 million cases of CKD in the G7 markets in 2021

Why is it a drug to watch?

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:

  1. ASCEND-ND (non-dialysis), ASCEND-D (dialysis), ASCEND-ID (incident dialysis) and ASCEND-TD (dialysis): daprodustat versus the standard of care, ESAs, resulting in hemoglobin within target levels and non-inferiority of major adverse cardiovascular events (MACE)
  2. ASCEND-NHQ: daprodustat versus placebo, resulting in increased hemoglobin and similar adverse events with daprodustat

In 2018, GSK plc and Kyowa Hakko Kirin entered into a strategic collaboration agreement for Kyowa Hakko Kirin to commercialize daprodustat in Japan.

Review and approval status

June 2020:
• Marketing authorization: MHLW

March 2022:
• Marketing authorization application (MAA) validated: European Medicines Agency (EMA)

April 2022:
• 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?

  1. In the face of competition, uptake of daprodustat might be fostered by its:
    • oral formulation (versus intravenous),
    • effective hemoglobin-raising efficacy for patients that have failed ESA therapy,
    • reduction in the need for iron supplementation and
    • likelihood for competitive pricing in comparison with the market-leading ESA brands.
  2. Given the complete response letters (CRLs) from the FDA for vadadustat and roxadustat, daprodustat has the opportunity to be first-in-class in the United States for this patient population.
  3. In Japan, Duvroq is leading market share (at ~47%) within the HIF class against four other competitors, despite being the second to launch.
  4. Many patients in Japan are switching from the current standard of care or starting their treatment with Duvroq.

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.

$0.53B
expected sales in 2027
95%
probability of success
for daprodustat in the United States.

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