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(Sharecast News) - AstraZeneca said on Tuesday that high-level results from the phase 3 'DAPA-CKD- trial of 'Farxiga', or dapagliflozin, showed a "statistically significant and clinically meaningful" effect on its primary endpoint.
The FTSE 100 pharmaceuticals giant said that endpoint was a composite of worsening of renal function or risk of death in adult patients with chronic kidney disease.
It said the trial also met all its secondary endpoints in chronic kidney disease patients with and without type-2 diabetes, making Farxiga the first medicine to significantly reduce the risk of death from any cause in that patient population.
AstraZeneca described chronic kidney disease as a serious, progressive condition defined by decreased kidney function, affecting nearly 700 million people worldwide, with many of them still undiagnosed.
Currently, there were limited treatment options for those patients, with chronic kidney disease associated with significant patient morbidity and an increased risk of cardiovascular events, such as heart failure and premature death.
"DAPA-CKD is the first trial to demonstrate overwhelming efficacy, including improvement on survival, in chronic kidney disease patients both with and without type-2 diabetes," said Mene Pangalos, executive vice-president of biopharmaceuticals research and development.
"We look forward to sharing these exciting Farxiga results with the scientific community and health authorities worldwide."
AstraZeneca said the safety and tolerability profile for Farxiga was consistent with the well-established safety profile of the medicine.
The full DAPA-CKD trial results would be submitted for presentation at an upcoming medical meeting.
In March, AstraZeneca announced that the DAPA-CKD trial was being stopped early, following a recommendation from an independent data monitoring committee, based on its determination of "overwhelming" efficacy.
Additionally, in May , Farxiga was approved in the United States to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure with reduced ejection fraction, with and without type-2 diabetes.
Farxiga was also under review with the European Medicines Agency, as well as in other regions, for the treatment of patients with heart failure.
At 0909 BST, shares in AstraZeneca were up 0.22% at 8,667p.
25 Mar 2024 09:04
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