The Food and Drug Administration (FDA) has granted Fast Track designation to dapagliflozin (Farxiga; AstraZeneca) as a possible treatment to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease (CKD).
Dapagliflozin is an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor that is currently approved under the brand name Farxiga as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D). The latest Fast Track designation is assigned to CKD patients with and without T2D.
The phase 3 ‘DAPA-CKD’ trial is currently evaluating the effect of dapagliflozin vs placebo on renal outcomes and CV mortality in patients with CKD. The Company also stated that they will instigate a clinical program called ‘DapaCare’, which will enroll almost 30,000 patients in randomized trials. These trials will investigate dapagliflozin in patients with established CV disease, CV risk factors and varying stages of renal disease.
Results from a separate trial in patients with reduced ejection fraction (DAPA-HF) found that dapagliflozin significantly reduced the risk of CV death or worsening heart failure when added to standard of care treatment in patients with reduced ejection fraction (HFrEF).
“We will work closely with the FDA to explore the potential for Farxiga to improve outcomes for these [CKD] patients,” said Mene Pangalos, EVP of BioPharmaceuticals R&D at AstraZeneca.
For more information visit AstraZeneca.com.