Zydus Cadila submits first NDA to DCGI for treatment of patients suffering from chronic kidney disease

Chronic kidney disease is a serious progressive medical condition, which is a global unmet healthcare

Zydus Cadila, an innovation-driven global pharmaceutical company announced that it has submitted the new drug application (NDA) to Drug Controller General of India for Desidustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of anaemia in patients with chronic kidney disease (CKD), who are on dialysis and not on dialysis.  

Chronic kidney disease is a serious progressive medical condition, which is a global unmet healthcare need involving gradual loss of functioning of kidneys eventually leading to kidney failure. It has been reported that 114 million people in India, 132 million people in China, 38 million people in the United States, 21 million patients in Japan and 41 million people in Western Europe are estimated to be living with chronic kidney disease (Lancet 2020; 395: 709–33). 

The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with chronic kidney disease (CKD) not on dialysis and on dialysis.