Approval

DCGI Approves Zyduss Oxemia For CKD Induced Anaemia

March 08,2022 10:10 AM
- By Admin

OxemiaTM is a hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor that is taken orally. In the DREAM-D and DREAM-ND Phase III clinical trials, Desidustat met its primary endpoints for haemoglobin improvement and demonstrated a good safety profile, as well as down regulation of hepcidin, improved iron mobilisation, and LDL-C reduction in CKD patients 

Zydus Lifesciences announced that the Drug Controller General of India (DCGI) has accepted its new drug application (NDA) for Oxemia (Desidustat), a first-ofits-kind oral medication for anaemia caused by chronic kidney disease. “There was a potential for an oral, safer alternative to the currently available injectable erythropoietin-stimulating agents (ESAs),” said Pankaj R Patel, Chairman, Zydus Lifesciences. OxemiaTM is a hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor that is taken orally. In the DREAM-D and DREAM-ND Phase III clinical trials, Desidustat met its primary endpoints for haemoglobin improvement and demonstrated a good safety profile, as well as down regulation of hepcidin, improved iron mobilisation, and LDL-C reduction in CKD patients Desidustat's clinical research programme, which included over 1200 people, was one of the largest trials of its kind in India for anaemia in CKD patients. Desidustat is an oral, easy therapeutic alternative for the treatment of anaemia in CKD patients.