2nd Oct 2020 07:38
(Alliance News) - AstraZeneca PLC on Friday said its drug Farxiga has been granted a breakthrough therapy designation in the US for chronic kidney disease patients.
The designation is for chronic kidney disease with and without type-2 diabetes and was granted by the US Food & Drug Administration. This designation is aimed at accelerating development and regulatory review for new medicines that treat serious conditions where there is significant unmet medical need.
To obtain a breakthrough therapy designation, a drug must show encouraging early clinical trial results showing substantial improvement for a clinically significant endpoint compared to medicines that are already available.
In the case of Farxiga, the designation follows the DAPA-CKD phase 3 trial in which "Farxiga demonstrated unprecedented reduction in the risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease", Astra said.
Detailed results from the trials found that Farixga plus standard care reduces the composite measure of worsening renal function, risk of cardiovascular death, or renal death by 39% versus placebo as well as reducing death from any cause by 31%.
Farixga is already indicated in the US as an adjunct to diet and exercise for improving blood sugar control in adults with type-2 diabetes as well as for reducing risk of being hospitalised for heart failure in type-2 diabetics with established cardiovascular disease or multiple cardiovascular risk factors.
Mene Pangalos, executive vice president of BioPharmaceuticals R&D at Astra, said: "There is a serious, unmet need for better and earlier treatment options for patients with chronic kidney disease. Following the ground-breaking DAPA-CKD results, the breakthrough therapy designation is further testament to Farxiga's potential to slow the progression of chronic kidney disease. We look forward to working with the FDA to make Farxiga available to patients as quickly as possible."
By Anna Farley; [email protected]
Copyright 2020 Alliance News Limited. All Rights Reserved.
Related Shares:
Astrazeneca