Zydus Lifesciences gets nod for new drug application of Desidustat Tablets

23 Apr 2024 Evaluate

Zydus Lifesciences has received approval from National Medical Products Administration of China (NMPA) for New Drug Application (NDA) of Desidustat Tablets. CMS International Development and Management, a wholly-owned subsidiary of China Medical System Holdings (CMS) obtained an exclusive license for the Product from Zydus in 2020.

Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients. CKD involves the gradual loss of functioning of kidneys and eventually leads to kidney failure. Healthy kidneys naturally secrete a hormone called Erythropoietin (EPO), which stimulates red blood cell production also known as erythropoiesis. When kidneys are impaired as in patients suffering from Chronic Kidney Disease, EPO production is impaired, leading to development of anaemia. HIF-PHI promotes erythropoiesis through increasing endogenous erythropoietin, reducing hepcidin thereby improves iron availability.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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