AstraZeneca (AZ) has revealed some impressive results from a phase 3 study of its heart failure drug Farxiga in chronic kidney disease (CKD) at the European Society of Cardiology (ESC) virtual congress.
In the DAPA-CKD trial, Farxiga (dapagliflozin) added to standard of care reduced the risk of cardiovascular or renal death and worsening of renal function by 39% compared to placebo in patients with CKD.
The results were consistent in patients both with and without type 2 diabetes, opening up the potential market for the SGLT2 inhibitor if it wins approval in this indication. The trial also met all key secondary endpoints, including significantly reducing death from any cause by 31% compared to placebo.
CKD affects nearly 700 million people worldwide, many of which are still undiagnosed, and is characterised by decreased kidney function. It is often caused by diabetes, hypertension and glomerulonephritis.
“With today’s results, Farxiga becomes the first SGLT2 inhibitor proven to significantly prolong the survival of patients with chronic kidney disease with and without type 2 diabetes and we look forward to sharing these data with regulatory authorities around the world,” said Mene Pangalos, executive vice president, biopharmaceuticals R&D at AZ.
“Farxiga is also the first medicine in its class to demonstrate benefit in treating both heart failure and chronic kidney disease in patients with and without type 2 diabetes, and reduce the risk of hospitalisation for heart failure and nephropathy in type 2 diabetes,” he added.
In March, the US Food and Drug Administration (FDA) fast-tracked Farxiga’s rival Jardiance (empagliflozin), co-developed by Eli Lilly and Boehringer Ingelheim, to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD.
This accelerated review was based on exploratory results from the EMPA-REG OUTCOME trial, which found that treatment with Jardiance reduced the risk of new-onset and worsening kidney disease by 39% in adults with type 2 diabetes and established cardiovascular disease compared with placebo.
Lilly/Boehringer are studying Jardiance in the ongoing EMPA-KIDNEY study to confirm Jardiance’s efficacy in CKD in patients with and without diabetes. The results from this study are not likely to be available until 2022, however, priming AZ’s Farxiga to become the first SGLT2 inhibitor to win approval in CKD.