India: approval for drug treating CKD-associated anaemia

Zydus Lifesciences received approval from the Drugs Controller General of India (DCGI) for its new drug application for Oxemia (Desidustat). Oxemia is a first-of-its-kind oral treatment, for anaemia associated with chronic kidney disease (CKD).

“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,” commented Pankaj R Patel, Chairman of Zydus Lifesciences. “There was a potential for an oral, safer alternative to currently available injectable erythropoietin-stimulating agents (ESAs).”

Zydus Lifesciences hace shared in a statement that Oxemia is a small molecule hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor.

“After more than a decade of research and development into the science of HIF-PH inhibitors, results have demonstrated that Oxemia addresses this unmet need and additionally reduces hepcidin, inflammation and enables better iron mobilization. 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,” Pankaj Patel added.

The clinical development for Oxemia saw one of the largest trials of its kind in India for anaemia in CKD patients, conducted in more than 1,200 patients.

CKD is a long-term condition characterised by the gradual loss of kidney function over time. CKD includes conditions that damage the kidneys and reduce their ability to continue filtering wastes from the blood. The condition can occasionally lead to kidney failure. Co-morbidities and complications include anaemia, cardiovascular diseases, high blood pressure, nerve damage, and diabetes mellitus. Symptoms for CKD include tiredness, shortness of breath, and blood present in urine.

According to industry estimates, 115.1 million people in India are currently living with CKD.

Ana Ovey