Last Updated on November 25, 2021 by The Health Master
Zydus Cadila, an innovation-driven, global pharmaceutical company, announced that it has submitted the New Drug Application (NDA) to the Drug Controller General of India (DCGI) for Desidustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of anemia in patients with chronic kidney disease (CKD) who are on dialysis and not on dialysis.
Desidustat met its primary efficacy endpoint in both phase 3 trials, DREAM-ND and DREAM-D, conducted in chronic kidney disease patients on dialysis and those not on dialysis.
The data will be presented at upcoming scientific meetings and published in peer-reviewed scientific journals.
“We are excited by this important milestone and thankful to all the patients, investigators, regulators, and scientists, who have led the discovery and development of Desidustat over the last decade.
Desidustat has the potential to provide an oral, safer alternative to currently available injectable erythropoietin- stimulating agents (ESAs), by additionally reducing hepcidin, reducing inflammation, and improving iron mobilization.
With patient-centricity at the core of all that we do, we have been looking at innovative approaches to improving the quality of life of patients and bridging unmet needs, and with Desidustat, we have taken yet another step in this direction.
Chronic kidney disease is a serious progressive medical condition that is a global unmet healthcare need, involving gradual loss of functioning of the kidneys, eventually leading to kidney failure.
It has been reported that the following estimated people to be living with chronic kidney disease (Lancet 2020; 395: 709–33):
- 114 million people in India,
- 132 million people in China,
- 38 million people in the United States,
- 21 million patients in Japan
- 41 million people in Western Europe
Desidustat had previously met its primary endpoints in the phase II clinical studies and showed a good safety profile, endogenous production of erythropoietin, down regulation of hepcidin, and improved iron mobilization in CKD patients.
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