Zydus receives DCGI approval for Oxemia to treat anaemia in CKD patients

Zydus Lifesciences has received approval for its New Drug Application (NDA) from the Drug Controller General of India (DCGI) for Oxemia (Desidustat), a first-of-its-kind oral treatment in India for anaemia associated with Chronic Kidney Disease (CKD), a company statement said.

Oxemia is an oral, small molecule hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor. Desidustat met its primary endpoints for haemoglobin improvement in the DREAM-D and DREAM-ND phase-III clinical trials and showed good safety profile, down regulation of hepcidin, improved iron mobilisation and LDL-C reduction in CKD patients. The clinical development programme of Desidustat was one of the largest trials of its kind in India for anaemia in CKD patients, conducted in more than 1,200 subjects. Desidustat provides CKD patients with an oral convenient therapeutic option for the treatment of anaemia.

Speaking on the development, Pankaj R Patel, Chairman, Zydus Lifesciences, said in the statement, “……..After more than a decade of research and development into the science of HIF-PH inhibitors, results have demonstrated that Oxemia (Desidustat) addresses this unmet need and additionally reduces hepcidin, inflammation and enables better iron mobilisation. This advancement offers ease of convenience for the patient and will also reduce the disease burden by providing treatment at an affordable cost, thereby improving the quality of life for patients suffering from Chronic Kidney Disease.”