AstraZeneca’s Farxiga Shows Overwhelming Efficacy In Phase III CKD Trial

AstraZeneca’s Farxiga could be closer to securing approval as a treatment for chronic kidney disease (CKD). This morning, the company said it halted its Phase III trial for this indication early due to “overwhelming efficacy.”

AstraZeneca said the Independent Data Monitoring Committee recommended halting the DAPA-CKD trial assessing Farxiga (dapagliflozin) due to the positive outcome that showed the drug was having a significant impact on patients. The trial data was showing that treatment with Farxiga was benefiting patients even earlier than originally anticipated, AstraZeneca said. Mene Pangalos, AstraZeneca’s head of BioPharmaceuticals R&D, hailed the decision to halt the trial early. He said Farxiga has the “potential to change the management of chronic kidney disease for patients around the world.” Pangalos added that chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes.

The primary endpoint of the Phase III DAPA-CKD trial is a composite of worsening of renal function or death, which was defined as “a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate, the onset of end-stage renal disease or cardiovascular (CV) or renal death) in patients with CKD irrespective of the presence of type-2 diabetes.” The full results will be submitted for presentation at a forthcoming medical meeting and AstraZeneca will now initiate discussions with global health authorities regarding early regulatory submissions.

In August, the U.S. Food and Drug Administration granted Fast Track designation for the development of Farxiga to delay the progression of renal failure and prevent cardiovascular and renal death in patients with chronic kidney disease. The Fast Track program is designed to accelerate the development and review of new medicines for the treatment of serious conditions where there is an unmet treatment need. For Farxiga, the Fast Track designation was assigned to CKD patients with and without type-2 diabetes.

CKD is a serious, progressive condition defined by decreased kidney function shown by reduced estimated glomerular filtration rate and/or markers of kidney damage for at least three months. The most common causes of CKD are diabetes and hypertension. CKD affects an estimated 200 million adults globally. The most severe form is end-stage renal disease, which typically results in death from CV causes.

In October, the FDA approved Farxiga to reduce the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. And in January of this year, the FDA accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type 2 diabetes. AstraZeneca’s supplemental New Drug Application was based on the results of the Phase III DAPA-HF and DELIVER trial that showed how the drug decreased the risk of heart failure. Approximately 40% of patients who participated in the trial had type 2 diabetes, a condition common among heart failure patients. AstraZeneca anticipates the FDA to make a ruling on the sNDA in the second half of this year.-Bio Space