Zydus Lifesciences has received approval for its New Drug Application (NDA) from the Drug Controller General of India (DCGI) for Oxemia (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.
Zydus Lifesciences is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.
Company Name | CMP |
---|---|
Sun Pharma Inds. | 1858.70 |
Dr. Reddys Lab | 1258.55 |
Cipla | 1559.20 |
Lupin | 2198.25 |
Zydus Lifesciences | 1004.00 |
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