New Delhi : , Nov 23, 2003 – Zydus Cadila, a major in the pharmaceutical industry, has applied for approval by the Drug Controller General of India.This is the highest drug regulator. Desidustat is an oral alternative to injectable erythropoietin-stimulating agents (ESAs) for the treatment of anemia caused due to chronic kidney disease.
Zydus stated in a statement, that Desidustat has been submitted to the DCGI as a new drug application (NDA).
Desidustat, an oral small-molecule hypoxia-inducible prolyl hydrolase (HIFPH), is used to treat anemia in chronic kidney disease patients.
Desidustat’s NDA is based upon positive results from DREAM ND Phase 2 and DREAM -D Phase 3 studies in chronic kidney disease patients.
Desidustat achieved its primary efficacy goal in Phase 3 clinical trials, DREAM ND and DREAM -D in patients with kidney disease.These data will be presented during the next scientific meetings.
They will also be published in peer reviewed scientific journals.
We are thrilled by this milestone, and grateful to all patients, researchers, regulators, and scientists who have contributed in any way possible to the development and discovery of Desidustat.
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 better iron mobilisation,” said Pankaj R.Patel, Chairman, Cadila.
A progressive and serious medical condition, chronic kidney disease can be fatal.According to a study, chronic kidney disease affects 114 million Indians, 132 millions in China, 38million in the US and 21 million in Japan.41 million Europeans are affected by it.
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