CDSCO approves AstraZeneca’s Dapagliflozin with additional indication for treating CKD and heart failure patients

The Central Drugs Standard Control Organization (CDSCO) has approved AstraZeneca’s anti-diabetic drug Dapagliflozin for the treatment of adults with Chronic Kidney Disease (CKD), a statement from AstraZeneca has notified.

Dapagliflozin is the first and only anti-diabetic drug approved to reduce the risk of sustained estimated Glomerular Filtration Rate (eGFR), cardiovascular deaths and hospitalisations due to heart failure in adults with progressive CKD. This approval is applicable for both diabetic and non-diabetic CKD patients, the statement said.

The approval is based on the consistent results from the DAPA-CKD study, where the indication has now been recommended in adults with CKD, up to an eGFR greater than or equal to 25 ml per min per 1.73 m2. Below this, the initiation is currently not recommended, however, patients may continue with their daily dose of 10 mg orally to reduce the risk of eGFR decline, End Stage Kidney Disease (ESKD), cardiovascular deaths and heart failures. Earlier, only up to CKD stage-III patients could be initiated Dapagliflozin, but, with this approval, physicians can initiate Dapagliflozin for a subset of CKD stage-IV.

Dr Anil Kukreja, Vice President – Medical Affairs and Regulatory, AstraZeneca India, said in the statement, “The timely approval of Dapagliflozin from the CDSCO committee with the additional indication is a huge boost for nephrologists across the country towards the management of progressive Chronic Kidney Disease……. 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.”