Daprodustat FDA approval time announced

Daprodustat (Daprodustat), as a new generation of HIF-PHI (hypoxia-inducible factor prolyl hydroxylase inhibitor) drugs, was officially approved by the U.S. FDA in 2023 in February Approved for the treatment of anemia due to chronic kidney disease (CKD) in adults. This approval not only marks it as the first oral CKD anemia treatment drug in the United States, but also symbolizes that the management of anemia in kidney disease has entered a new stage of treatment after relying on injectable red-stimulating drugs for many years. FDA regarded it as an innovative drug with "first-in-class" attributes during its review, reflecting its uniqueness in mechanism and clinical significance.

From the perspective of approval background, for a long time CKD anemia has mainly relied on intravenous or subcutaneous injection of erythropoiesis-stimulating agents (ESA). However, ESA has unstable responses in some patients, potential risks of cardiovascular events, and compliance issues caused by injection routes. The medical community has been looking forward to alternatives that are more operable and more consistent with disease course management. The launch of dapinostat meets this demand. Its oral administration method helps reduce the frequency of patients traveling to and from medical institutions. It is also more in line with the characteristics of long-term and regular management of chronic diseases and is conducive to improving patient compliance.

The FDA's approval was based on multiple international studies and comprehensive analyzes that focused on its performance in maintaining hemoglobin levels, improving anemia symptoms, regulating iron metabolism, and long-term safety. The mechanism of dapoprimostat is different from traditional ESA. It regulates the HIF pathway in the body, causing the body to produce a redness-promoting response that is more in line with circadian rhythms, and at the same time promotes iron utilization and regulation. This "simulating mild hypoxia" mechanism is considered to be closer to the natural physiological state.

Its approval not only changed the CKD anemia treatment landscape in the United States, but also provided regulatory reference for many countries around the world. Experts in the international kidney field generally believe that the emergence of HIF-PHI drugs provides more options for patients who cannot inject ESA regularly, have insufficient response to ESA or need to adjust iron metabolism.

References: https://en.wikipedia.org/wiki/Daprodustat