AstraZeneca's Farxiga claims first SGLT2 kidney disease OK from FDA

chronic kidney disease

AstraZeneca is already seeing sales rocket for its SGLT2 inhibitor Farxiga in heart failure, and is expected to gather even more momentum after claiming FDA approval in chronic kidney disease (CKD). 

The US regulator has cleared Farxiga (dapagliflozin) to reduce the risk of kidney damage, end-stage kidney disease, cardiovascular, death and hospitalisation for heart failure in adults with CKD who are at risk of progression.

Farxiga – known as Forxiga in some markets – is the first in the SGLT2 inhibitor class to get a CKD indication on its US label, opening up a sizeable new indication for the drug. There are around 37 million people in the US alone with CKD.

AZ's dug is already in the ascendency, with first-quarter sales rising more than 50% to top $625 million, closing the gap between the drug and top-selling SGLT2 drug Jardiance (empagliflozin) from Eli Lilly and Boehringer Ingelheim, thanks largely to its approval in the US as a therapy for heart failure with reduced ejection fraction (HFrEF) a year ago.

Boehringer and Lilly are hoping to fight back with a marketing application for Jardiance in HFrEF later this year, currently under fast-track review by the FDA, but the new CKD indication allows AZ to ratchet up the pressure on the market leader once again.

The latest approval is based on the phase 3 DAPA-CKD trial, which showed Farxiga achieved a statistically significant 39% reduction in the composite endpoint of worsening renal function or risk of death compared to placebo in CKD patients.

Farxiga also significantly reduced the relative risk of death from any cause by 31% compared to placebo in the trial.

Cardiovascular outcome studies with Farxiga and other SGLT2 inhibitors had suggested the drugs could have a protective effect on the kidney in type 2 diabetes, but DAPA-CKD was the first large-scale trial to test an SGLT2 drug specifically in both diabetic and non-diabetic patients with CKD.

AZ's head of biopharmaceuticals R&D, Mene Pangalos, said the approval is "the most significant advancement in the treatment of chronic kidney disease in more than 20 years".

Pangalos has said previously are an additional 2.7 million CKD patients in the US without heart failure that could potentially be treated with Farxiga, although he acknowledged that under diagnosis is a problem. At the moment, only 12% of qualifying CKD patients are formally diagnosed in the US, according to AZ.

Lilly and Boehringer meanwhile are in hot pursuit of a CKD indication for Jardiance, to try to defend their franchise.

The two partners are carrying out the EMPA-KIDNEY trial in CKD patients with and without diabetes, with results due in 2022, although its possible that they could be stopped early like DAPA-CKD if the data are similarly strong.