On March 7, 2022, Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd., “Zydus”), a collaborative partner of China Medical System Holdings Limited (“CMS”), 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).
According to Zydus’ Press Release:
“Desidustat 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.
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 globally.”
In China, CMS has localized the manufacturing of Desidustat Tablets’ preparations used for clinical trials through technology transfer. In June 2021, CMS completed the product’s Phase I pharmacokinetic (PK) study. In January 2022, CMS completed the first subject dosing in the product’ Phase III bridging trial.
Further information can be found in the Zydus’ Press Release：
https://www.bseindia.com/xml-data/corpfiling/AttachLive/00ea819d-837e-47b2-b457-53d7789b6b99.pdf