New Delhi: Pharma company Zydus Cadila has sought approval from the Drug Controller General of India for a new drug named Decidestat.
Decidestat is an oral alternative to injectable erythropoietin-stimulating agents (ESA), ie an oral tablet, for the treatment of anemia caused by chronic kidney disease.
Zydus said in a statement that it has submitted a new drug application (NDA) for Decidstat to DCGI.
Decidestat is an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) for the treatment of anemia in patients with chronic kidney disease.
The DNA is based on positive data from trials in Phase 3 of DREAM-ND and DREAM-D in chronic kidney patients.
Decidestat met its primary efficacy endpoint in both DREAM-ND and DREAM-D, Phase 3 trials conducted in kidney patients. The data will be presented at upcoming scientific meetings and published in review scientific journals.
Cadila President Pankaj R. We are excited by this important milestone and are grateful to all the patients, investigators, regulators and scientists who led the discovery and development of DecidStat over the past decade. Decidestat has the potential to provide an oral, safer alternative to the currently available injectable erythropoietin.
Chronic kidney disease is a serious progressive medical condition. According to a report, 114 million people are estimated to be suffering from chronic kidney disease in India, 132 million in China, 38 million in America, 21 million in Japan and 41 million in Western Europe.
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