AstraZeneca's Farxiga’s (dapagliflozin) has hit all primary and secondary endpoints in a late stage trial assessing its use in patients with chronic kidney disease (CKD).
The Phase III DAPA-CKD trial, which was stopped early because of the drug's strong performance, showed a statistically significant and clinically meaningful effect on its primary endpoint of a composite of worsening of renal function or risk of death in adults CKD.
The trial also met all its secondary endpoints in CKD patients with and without type II diabetes, which AZ says makes Farxiga the first medicine to significantly cut the risk of death from any cause in this patient population.
CKD is a serious, progressive condition defined by decreased kidney function affecting nearly 700 million people worldwide, with many of them still undiagnosed. The condition is linked with significant patient morbidity and an increased risk fo CV events, and there are limited treatment options.
“The DAPA-CKD trial has shown dapagliflozin’s potential as a long-awaited new treatment option for patients with chronic kidney disease. The data will be transformative for these patients,” said co-chairs of the trial and its executive committee Professor David Wheeler, University College London, and Professor Hiddo L. Heerspink, University Medical Center Groningen.
“DAPA-CKD is the first trial to demonstrate overwhelming efficacy, including improvement on survival, in chronic kidney disease patients both with and without type II diabetes,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D. “We look forward to sharing these exciting Farxiga results with the scientific community and health authorities worldwide.”
The company did not reveal specific data at this time, but said it would submit results of the trial for presentation at medical meeting.