Zydus bags DCGI approval for ‘anaemia associated with CKD’ drug Oxemia

Zydus Lifesciences has received approval for its New Drug Application (NDA) from the Drug Controller General of India for Oxemia (Desidustat), a first-of-its-kind oral treatment in India for anaemia associated with Chronic Kidney Disease (CKD). Oxemia is an oral, small molecule hypoxia-inducible factor-prolyl hydroxylase (HIFPH) inhibitor. Desidustat met its primary endpoints for haemoglobin improvement in the DREAM- D and DREAM-ND Phase III clinical trials and showed a good safety profile, downregulation 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 over 1200 subjects. Desidustat provides CKD patients with an oral convenient therapeutic option for the treatment of anaemia.