Dapagliflozin Gets Breakthrough Therapy Designation for CKD

October 2, 2020

The FDA action follows presentation of results in August during the European Society of Cardiology 2020 Virtual Congress.

FDA has granted dapagliflozin (Farxiga, AstraZeneca) breakthrough therapy designation for patients with chronic kidney disease (CKD), both with and without type 2 diabetes (T2D).

The decision comes following the presentation of results from the DAPA-CKD trial, which showed that dapagliflozin brought a 39% decline in the risk of declining renal function or cardiovascular or renal death when given alongside standard of care. Results also showed dapagliflozin reduced the risk of death from any cause by 31%.

The findings were presented August 30 during the European Society of Cardiology 2020 Virtual Congress.

In the United States, 37 million patients have CKD, which can lead to the need for dialysis and is strongly linked with heart disease and stroke. CMS has taken steps to prevent patients from progressing to later-stage kidney disease, both to preserve quality of life and to reduce the large share of Medicare spending that goes for kidney-related care. Federal officials estimate that while 1% of Medicare beneficiaries have kidney disease, it accounts for 7% of all spending.

“There is a serious, unmet need for better and earlier treatment options for patients with chronic kidney disease,” Mene Pangalos, executive vice president, BioPharmaceuticals R&D for AstraZeneca, said in a statement. “Following the ground-breaking DAPA-CKD results, the breakthrough therapy designation is further testament to Farxiga’s potential to slow the progression of chronic kidney disease. We look forward to working with the FDA to make Farxiga available to patients as quickly as possible.”

Dapagliflozin is part of a class of drugs called sodium glucose co-transporter 2 (SGLT2) inhibitors, which were originally developed to treat T2D. The drugs work by targeting a protein that blocks the mechanism that causes the body to reabsorb excess glucose; instead, it is expelled from the body through the urine.

SGLT2 inhibitors have also been found to be effective in reducing the risk of heart failure specifically, dapagliflozin is approved to reduce the risk of hospitalization for heart failure in patients with T2D and established cardiovascular (CV) disease or multiple CV risk factors. In May, FDA approved dapagliflozin to reduce the risk of CV death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction, whether or not they have T2D.