Zydus Lifesciences receives DCGI approval for Oxemia
NEW DELHI: 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 Oxemia (Desidustat), afirst-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 DREAMD 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 erythropoietinstimulating agents (ESAs). After more than a decade of research and development into the science of HIF-PH inhibitors, results have demonstrated that OxemiaTM (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.”
Zydus is amongst the top players in the Nephrology segment with a super-speciality portfolio with brands like Zyrop, Grafalon, Tacromus and Mycomune. With OxemiaTM, the group posts a new milestone in its innovation journey which has seen the commercialisation of several novel therapies.
Chronic kidney disease (CKD) is a serious progressive medical condition characterized by a gradual loss of kidney function, usually accompanied by other comorbidities including anemia, cardiovascular diseases (hypertension, heart failure and stroke), diabetes mellitus, eventually leading to kidney failure. CKD patients are often on multiple medications and are at safety risks of drug-drug interactions. It has been reported that 115.1 million people in India, 132 million in China, 38 million in the United States, 21 million in Japan and 41 million people in Western Europe are estimated to be living with Chronic Kidney Disease (Lancet 2020; 395: 709–33). CKD is predicted to become one of the most common causes of premature death by 2040.
Results of multiple studies of OxemiaTM (Desidustat) have been published in various international peer-reviewed scientific journals of repute such as American Journal of Nephrology, Clinical Pharmacokinetics, European Journal of Pharmacology, Journal of Medicinal Chemistry, Drug Development Research, Drug Research (Stuttg) and Xenobiotica.