Cadila Healthcare on Tuesday announced that it submitted the New Drug Application (NDA) to the Drug Controller General of India (DCGI) for Desidustat.Desidustat is an oral small molecule hypoxia-inducible inhibitor used for treatment of anaemia in patients with chronic kidney disease (CKD) who are on dialysis and not on dialysis. 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 not on dialysis and on dialysis.
Cadila said that Desidustat met its primary efficacy endpoint in both Phase 3 trials, DREAM-ND and DREAM-D, conducted in chronic kidney disease (CKD) patients. The data will be presented at upcoming scientific meetings and published in peer-reviewed scientific journals.
Pankaj R. Patel, chairman of Cadila Healthcare said, We are excited by this important milestone and thankful to all the patients, investigators, regulators and scientists, who 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 erythropoietinstimulating agents (ESAs), by additionally reducing hepcidin, reducing inflammation, and better iron mobilisation. 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.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The company's consolidated net profit surged 608.10% to Rs 2,999.60 crore on 2.4% increase in net sales to Rs 3,687 crore in Q2 FY22 over Q2 FY21.
Shares of Cadila Healthcare were trading 0.26% higher at Rs 457.45 on BSE.
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