AstraZeneca India's anti-diabetes drug gets approval from drug regulator

Drug firm AstraZeneca India on Tuesday said it has received approval from the country's drug regulator to market anti-diabetes medication Dapagliflozin.

The company said it has received approval from the Central Drugs Standard Control Organization (CDCSCO) for the drug indicated for diabetes patients with chronic kidney disease (CKD).

Dapagliflozin is the first and only anti-diabetic drug approved to significantly reduce the risk of sustained eGFR (estimated Glomerular Filtration Rate), cardiovascular deaths and hospitalisations due to heart failure in adults with progressive chronic kidney disease, the drug firm said.

The approval is applicable for both diabetic and non-diabetic CKD patients, it added.

CKD is one of the leading causes of hospitalisation globally and in India, representing a significant clinical and economic burden.

"The timely approval of Dapagliflozin from the CDCSCO committee with the additional indication is a huge boost for nephrologists across the country towards the management of progressive CKD," AstraZeneca India Vice President - Medical Affairs and Regulatory Anil Kukreja said in a statement.

The approval will provide the clinical community with a potential therapeutic option to arrest the progression of CKDs and address heart failures at an early stage, he added.

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