Zydus Lifesciences gets DCGI approval for Oxemia drug

Ahmedabad (Gujarat) [India], March 7 : Zydus Lifesciences on Monday said it has received approval from the Drug Controller General of India (DCGI) for a new drug application, Oxemia (Desidustat), a first-of-its-kind oral treatment in India for anemia associated with chronic kidney disease.
Oxemia is an oral, small molecule hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor.
The clinical development programme of Oxemia (Desidustat) was one of the largest trials of its kind in India for anemia in chronic kidney disease (CKD) patients, conducted in over 1200 subjects.
Desidustat provides CKD patients with an oral convenient therapeutic option for the treatment of anemia.
"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," Pankaj R Patel, Chairman, Zydus Lifesciences Ltd, said in a statement.
"There was a potential for an oral, safer alternative to currently available injectable erythropoietin- stimulating agents (ESAs). After more than a decade of research and development into the science of HIF-PH inhibitors, results have demonstrated that Oxemia (Desidustat) addresses this unmet need and additionally reduces hepcidin, inflammation and enables better iron mobilisation," Patel said.
Chronic kidney disease (CKD) is a serious progressive medical condition characterised 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.