Zydus seeks DCGI nod for 'Desidustat' oral pill to treat anaemia in kidney patients

Pharmaceutical company Zydus Cadila on Tuesday announced that it has submitted its first "New Drug Application (NDA)" to the Drug Controller General of India for its oral pill "Desidustat" to treat anaemia in kidney patients.

As per the press release of the company, Desidustat is 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.

"Desidustat met its primary efficacy endpoint in both Phase 3 trials, DREAM-ND and DREAM-D, conducted in Chronic Kidney Disease (CKD) patients on Dialysis and Not on Dialysis," it further said.

Chairman of Cadila Healthcare Limited, Pankaj R. Patel thanked all the patients, investigators, regulators and scientists, who led the discovery and development of Desidustat over the last decade for this "important milestone.

Talking about the drug, Patel said, "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."

"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," he added.

The release said that Desidustat had previously met its primary endpoints in Phase II clinical studies and showed a good safety profile, endogenous production of erythropoietin, downregulation of hepcidin, improved iron mobilization in CKD patients.

"The Phase I trials were earlier completed in Australia. Desidustat is also under clinical trials for Cancer Chemotherapy Induced Anemia (CIA)," it further read.

( With inputs from ANI )

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