FDA Approves Dapagliflozin for CKD Patients

The US Food and Drug Administration has approved dapagliflozin (Farxiga; AstraZeneca) to reduce the risk of renal and cardiovascular adverse events in patients with chronic kidney disease (CKD) who are at risk of disease progression, irrespective of whether they have diabetes.

On the strength of the DAPA-CKD trial, which was presented at last year’s virtual European Society of Cardiology Congress, dapagliflozin is now indicated to reduce the risk of declining kidney function, kidney failure, cardiovascular mortality, and hospitalization for heart failure in adults with CKD.

This makes dapagliflozin the first sodium-glucose cotransporter 2 (SGLT2) inhibitor to be approved for the treatment of CKD regardless of diabetes status. Dapagliflozin and other SGLT2 inhibitors were initially developed for patients with type 2 diabetes, but the drugs have shown far-reaching benefits in different patient populations, specifically patients with HF with reduced ejection fraction (HFrEF) with or without diabetes. 

In the DAPA-CKD trial, as reported by TCTMD, dapagliflozin added to usual care reduced the primary composite endpoint, one that included renal and cardiovascular events and mortality, by 39% when compared with usual care alone. The trial was unique in that one-third of patients did not have diabetes, and yet these patients derived the same benefit as those with diabetes.

In the US, dapagliflozin is currently approved to improve glycemic control in adults with type 2 diabetes and to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. It is also approved to reduce the risk of cardiovascular mortality and hospitalization for heart failure in adults with HFrEF with or without type 2 diabetes.