AstraZeneca unveils Phase III kidney treatment results

15-Sep-2020 - Last updated on 15-Sep-2020 at 16:09 GMT

(peterschreiber.media/iStock via Getty Images Plus)

In a Phase III trial, Farxiga reportedly showed reduction in the risk of kidney failure, and cardiovascular (CV) or renal death, in CKD patients.

The results from the Phase III DPA-CKD trial showed promising results in patients with chronic kidney disease (CKD), AstraZeneca has reported. According to the pharma company, Farxiga (dapagliflozin) is the first therapy shown to significantly prolong patient survival in CKD patients, both with and without Type 2 diabetes.

Detailed trial results indicated that administering Farxiga on top of standard of care reduced the composite measure of worsening of renal function or risk of CV or renal death by 39% compared to placebo (p<0.0001) in patients with Stage 2-4 CKD elevated urinary albumin excretion. Reported results were consistent in patients both with and Type 2 diabetes (T2D).

Joris Silon, AstraZeneca senior vice president of Global Cardiovascular, Renal and Metabolism (CVRM), told Outsourcing-Pharma CKD is a progressive disease typified by decreased kidney function that impacts nearly 700m people worldwide, many not yet diagnosed. Silon added that the Centers for Disease Control and Prevention (CDC) report about 15% of adults in the US (approximately 37m patients) are likely to have CKD, Stages 1-4.

“A newly diagnosed patient can feel overwhelmed and afraid; CKD is associated with significant patient morbidity and an increased risk of CV events, including heart failure (HF) and premature death,” he told us. “Outside of lifestyle adjustments that can help control risk factors and disease progression, their treatment options are limited, and no cure exists.”

The current standard of care for progressive CKD, Silon said, is renin-angiotensin-aldosterone system (RAAS) blockade with angiotensin converting enzyme inhibitors (ACE-is) or angiotensin II receptor blockers (ARBs). Further, treatment options for CKD patients have not progressed enough in recent years, he said.

“We haven’t had significant advancements in CKD treatment in 20 years, and it’s time for change,” he said. “People living with CKD are in urgent need of new solutions to slow disease progression and treat life-threatening complications.”

The primary composite endpoint of the Phase III study was ≥50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end-stage kidney disease (ESKD) and CV or renal death. Absolute risk reduction (ARR) was 5.3% over the median time in study of 2.4 years; the trial also met all secondary endpoints, including significantly reducing death from any cause by 31% (ARR = 2.1%, p=0.0035) compared to placebo.

The co-chairs of the DAPA-CKD trial were executive committee professor David Wheeler, University College London, UK; and professor Hiddo Heerspink, University Medical Center Groningen, the Netherlands. In a joint statement, the professors said, “The impressive DAPA-CKD trial results are a remarkable development for patients with chronic kidney disease; these data have the potential to transform the standard of care for this patient population, which has a significant unmet need for new and improved treatment options.”

Silon added the work on Farxiga demonstrates a continued pursuit of better outcomes for CV patients.

“We believe patients deserve more and better – and we’re committed to making that happen by leveraging our legacy in CV disease, following the science to better understand the interconnectivity of CKD with other conditions and modernizing approaches to CKD care,” he told OSP. “The ground-breaking Phase III DAPA-CKD trial is the most recent example of our work to shift the paradigm in CKD treatment and a remarkable development for patients.”