Trial shows AZ’s Farxiga slows onset of chronic kidney disease and cuts mortality

AstraZeneca’s Farxiga could be on course for another use, after trial results showed it slowed the worsening of renal function and cut the risk of death in patients with chronic kidney disease with and without type 2 diabetes.

Farxiga (dapagliflozin), an oral once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor, started life as a diabetes drug but AZ has begun trialling it in other cardiovascular and metabolic diseases.

It’s part of an ongoing trend started by Eli Lilly and Boehringer Ingelheim, who showed that their rival SGLT2 diabetes drug Jardiance (empagliflozin) cut the chances of cardiovascular events in high-risk patients with type 2 diabetes in 2016’s landmark EMPA-REG OUTCOMES trial.

Farxiga has already picked up indications to reduce risk of hospitalisation in heart failure patients with type 2 diabetes, and as a standalone treatment for heart failure in patients with reduced ejection fraction.

Last year, the FDA badged Farxiga as a Fast Track drug in chronic kidney disease, and also decided to offer the same level of regulatory support to Jardiance earlier this year.

The high level results from the phase 3 DAPA-CKD trial announced today show Farxiga produced a “statistically significant and clinically meaningful” effect when measured against a composite endpoint of worsening renal function or risk of death.

The endpoint was defined as a decline of at least 50% sustained decline in estimated glomerular filtration rate, onset of end stage kidney disease or cardiovascular renal death, in adult CKD patients with or without type 2 diabetes.

The trial also met all its secondary endpoints and AZ noted that Farxiga is therefore the first medicine to significantly reduce the risk of death from any cause in this patient population.

AZ added that the safety and tolerability profile for Farxiga was consistent with the well-established safety profile of the medicine.

The full DAPA-CKD trial results will be submitted for presentation at a forthcoming medical meeting.

Mene Pangalos, executive vice president of BioPharmaceuticals R&D, at AZ said that regulatory filings will follow.

He said: “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.

“We look forward to sharing these exciting Farxiga results with the scientific community and health authorities worldwide.”


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