The drug company AstraZeneca India announced on Tuesday that it received approval from the country’s drug regulator in order to market the anti-diabetes medication Dapagliflozin on the Indian market.
CDCSCO (Central Drugs Standard Control Organization) has approved the company’s drug for patients with diabetes and chronic kidney disease (CKD).
In adults with progressive chronic kidney disease, the drug firm announced that dapagliflozin is the only antidiabetic drug approved to significantly reduce the risk of sustained eGFRs, cardiovascular deaths and hospitalizations due to heart failure.
Both diabetic and non-diabetic patients with CKD are eligible for approval.
There is a significant clinical and economic burden associated with chronic kidney disease globally and in India.
The CDCSCO committee has approved dapagliflozin in a timely manner with an additional indication, which provides nephrologists across the country with an important tool for managing progressive renal disease (CKD). Anil Kukreja, Vice President of Medical Affairs and Regulatory at AstraZeneca India, commented.
According to him, the approval will provide a potential therapeutic option to arrest the progression of chronic kidney disease and address heart failures at an early stage.
