Farxiga smashes all goals in Phase 3 chronic kidney disease trial, says AstraZeneca

pharmafile | July 28, 2020 | News story | Manufacturing and Production, Research and Development AstraZeneca, farxiga 

AstraZeneca has teased new data from a Phase 3 study of its sodium-glucose co-transporter-2 (SGLT2) inhibitor Farxiga (dapagliflozin) in the treatment of chronic kidney disease in adult patients, revealing that the therapy hit all of its primary and secondary endpoints.

The pharma firm evaluated the safety and efficacy of the drug in 4,304 patients across 21 countries throughout the study, and reported that Farxiga successfully reduced the worsening of renal function or risk of death associated with the condition, as measured by a sustained decline of at least 50% in estimated glomerular filtration rate (eGFR), onset of end stage kidney disease (ESKD) or cardiovascular (CV) or renal death, meeting its main goal.

Furthermore, the drug also met all of its secondary endpoints of time to first occurrence of the renal composite, the composite of CV death or hospitalisation for heart failure, and death from any cause.

Due to a showing of “overwhelming efficacy”, the trial was ultimately stopped early in March this year after a recommendation from an independent Data Monitoring Committee.

Mene Pangalos, Executive Vice President of AZ’s BioPharmaceuticals R&D, said it was the “first trial to demonstrate overwhelming efficacy, including improvement on survival, in chronic kidney disease patients both with and without type-2 diabetes.”

Full results from the trial were promised to appear at an upcoming medical meeting.

Matt Fellows

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