Zydus gets DCGI nod for oral drug to treat anemia in CKD patients

Zydus gets DCGI nod for oral drug to treat anemia in CKD patients
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AHMEDABAD: Zydus Lifesciences Ltd (formerly known as Cadila Healthcare Ltd), one of the leading pharmaceuticals companies in the country, on Monday announced that it has received approval for its new drug application (NDA) from the Drug Controller General of India (DCGI) for OxemiaTM (Desidustat), a first-of-its-kind oral treatment in the country for anemia associated with chronic kidney diseases (CKD).

OxemiaTM is an oral, small molecule hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor, and is seen as an alternative to injectable erythropoietin-stimulating agents (ESAs).

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. 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 CKD, as per a media statement by the Ahmedabad-based Zydus. It is predicted to become one of the most common causes of premature death globally by 2040.

The clinical development programme of Desidustat was one of the largest trials of its kind in India for anemia in CKD patients, conducted in more than 1,200 subjects, the company informed. Desidustat provides CKD patients with an oral convenient therapeutic option to treat anemia, it further said.

“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. 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 OxemiaTM (Desidustat) addresses this unmet need and additionally reduces hepcidin, inflammation and enables better iron mobilisation,” according to Pankaj Patel, chairman of Zydus Lifesciences Ltd.

This medical advancement offers the 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 CKD, he added.

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