Zydus develops new treatment for patients suffering from Chronic Kidney Disease (CKD)

The company submits first New Drug Application (NDA) to DCGI
Read Article

Zydus Cadila today 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 treatment of anaemia in patients with Chronic Kidney Disease (CKD) who are on dialysis and not on dialysis.

In a statement, the company said that the NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D phase-III trials in patients with CKD not on dialysis and on dialysis. The DREAM-ND phase-III trial of 588 CKD patients not-on-dialysis compared Desidustat versus Darbepoietin alpha injection. In the Desidustat group, mean Hb increased and reached the predefined target of 10.0–12.0 g/dl in patients and was maintained within the target range for 24 weeks. The study demonstrated the non-inferiority of Desidustat compared to Darbepoetin in the treatment of anemia in patients with CKD who were not on dialysis.

The DREAM-D phase-III trial of 392 CKD patients on dialysis compared Desidustat tablet versus Epoetin alfa injection. In the Desidustat group, mean Hb increased and reached the predefined target of 10.0–12.0 g/dl in patients and was maintained within the target range for 24 weeks. The study demonstrated the non-inferiority of Desidustat compared to Epoetin in the treatment of anemia in patients with CKD who were on dialysis.

Desidustat met its primary efficacy endpoint in both phase-III trials, DREAM-ND and DREAM-D, conducted in Chronic Kidney Disease (CKD) patients on dialysis and 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 led the discovery and development of Desidustat over the last decade. Desidustat has the potential to provide an oral and safer alternative to currently available injectable erythropoietin- stimulating 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, ” said Pankaj R Patel, Chairman, Cadila Healthcare.

The statement further said that Desidustat had previously met its primary endpoints in the phase-II clinical studies and showed good safety profile, endogenous production of erythropoietin, downregulation of hepcidin, improved iron mobilisation in CKD patients. The phase-I trials were earlier completed in Australia. Desidustat is also under clinical trials for Cancer Chemotherapy Induced Anemia (CIA).

The data of Desidustat (ZYAN1) has so far been published in various peer-reviewed scientific journals such as American Journal of Nephrology, Clin Pharmacokinet, European Journal of Pharmacology, Journal of Medicinal Chemistry, Drug Dev Res, Drug Res (Stuttg) and Xenobiotica, the statement concluded.

Chronic Kidney Disease treatmentDarbepoietin alpha injectionDCGIDesidustatNDAZydus Cadila
Comments (0)
Add Comment