USA –GSK announced that the US Food and Drug Administration has approved a new drug application for daprodustat for people with chronic kidney disease (CKD) who also have anemia.

GSK submitted daprodustat based on its ASCEND phase 3 program, which included five trials in dialysis and non-dialysis patients and demonstrated that the drug provided an oral alternative to injectable erythropoietin stimulating agents (ESAs) for anemia without sacrificing efficacy.

The FDA regulatory submission acceptance is the third major regulatory milestone for daprodustat. It comes after the acceptance of the European Medicines Agency (EMA) regulatory submission and the approval of Duvroq in Japan.

Daprodustat was created on the basis of groundbreaking Nobel Prize-winning research that demonstrated how cells sense and adapt to oxygen availability.

The FDA has set a February 1, 2023 action date for the Prescription Drug User Fee Act (PDUFA). The act, enacted in 1992, allows the FDA to collect fees from companies that manufacture certain human drugs and biological products.

Last August, the US Food and Drug Administration rejected FibroGen and AstraZeneca’s roxadustat, requesting another clinical trial before considering approval, citing cardiovascular safety concerns.

Then, just last month, it rejected Akebia’s vadadustat, claiming that the data “do not support a favorable benefit-risk assessment of vadadustat for dialysis and non-dialysis patients.”

Despite these setbacks, GSK remains the market leader in the US hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) category, buoyed by the prior approval of daprodustat in Japan, where it is marketed as Duvroq by partner Kyowa Kirin.

However, prior approval elsewhere is no guarantee of FDA success, as roxadustat was rejected despite being available in Japan since 2019 and Europe since last year.

The ASCEND program includes five Phase III trials to evaluate daprodustat’s efficacy and safety profile in treating CKD anemia across the disease pathway.

Over 8,000 patients were enrolled in the program, who were treated for up to 4.26 years. The findings from all five trials were presented at Kidney Week 2021, hosted by the American Society of Nephrology.

CKD, which is characterized by progressive loss of kidney function, is a growing global public health burden, and anemia is a common and important complication of CKD.

It is frequently misdiagnosed and undertreated in patients with early-stage CKD who are not on dialysis.

Hypertension, diabetes, obesity, and primary renal disorders are all risk factors for CKD. CKD is also a risk factor for cardiovascular disease on its own.

It is estimated that 700 million people worldwide suffer from chronic kidney disease, with one in every seven also suffering from anemia.

Analysts, however, do not expect daprodustat, also known as Duvroq, to move the needle. Peak sales are expected to range between £500 million (US$651.1million) and £1 billion (US$1.3 billion).

To put this in context, GSK’s sales last year totaled £34 billion (US$44.3billion).

Anemia of CKD, if left untreated or undertreated, is associated with poor clinical outcomes and imposes a significant burden on patients and healthcare systems.

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