Zydus to launch Desidustat breakthrough treatment for Anemia in CKD patients under brand name Oxemia
Oxemia is an oral, small molecule hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor.;
Ahmedabad: Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), a discovery-driven, global lifesciences company announced that it has received approval for its New Drug Application (NDA) from the Drug Controller General of India for OxemiaTM (Desidustat), a first-of-its-kind oral treatment in India for anemia associated with Chronic Kidney Disease (CKD).
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, downregulation of hepcidin, improved iron mobilization 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 Anemia in CKD patients, conducted in over 1200 subjects. Desidustat provides CKD patients with an oral convenient therapeutic option for the treatment of anemia.
Speaking on the development, Pankaj R. Patel, Chairman, Zydus Lifesciences Ltd., said, "Our life changing discoveries are guided by the need to help patients lead a better life and empower them with therapies that enable them to live healthier and more fulfilled lives. There was a potential for an oral, safer alternative to currently available injectable erythropoietin- stimulating agents (ESAs). 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."
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