September 1,2020

AstraZeneca set the tone for the future of SGLT2 diabetes medicines in May with Farxiga's heart-helping FDA approval in patients with or without diabetes. Now, the company is looking to change the game again in kidney disease—and outcomes data from a halted pivotal study certainly adds some heft. 

Farxiga cut the combined risk of worsening kidney function, end-stage kidney disease onset, and kidney disease- or cardiovascular-related death by 39% over placebo in patients with chronic kidney disease with or without Type 2 diabetes, according to late-breaking science presented Sunday at the European Society of Cardiology virtual annual meeting. 

In what AstraZeneca is calling "paradigm-shifting" findings, Farxiga's Dapa-CKD outcomes trial showed the drug also sliced the risk of all-cause mortality by 31% over placebo, a key secondary endpoint. Those results were consistent across patients regardless of whether they had a diabetes diagnosis. 

Farxiga, an SGLT2 inhibitor originally approved to control blood sugar, scored a first-of-its-kind FDA nod in May to lower the risk of major CV events in heart failure patients with or without diabetes. 

AstraZeneca painted its kidney disease findings in much the same terms as its heart failure data, calling the results "landmark" and "game-changing." While Johnson & Johnson's Invokana sports an FDA approval in diabetic kidney disease, a potential nod for Farxiga would make it the first SGLT2 on the market for kidney patients without diabetes. 

"I wish my medicine textbooks had data like this—this data really has the potentially to rewrite those textbooks," said Rachele Berria, AstraZeneca's vice president of U.S. medical for biopharmaceuticals. 

AstraZeneca released its top-line findings late last month after halting the trial early in March, when interim data "showed Farxiga's benefits earlier than originally anticipated," the drugmaker said at the time. 

Kiersten Combs, AstraZeneca's vice president of cardiovascular and metabolic disease, said Farxiga's newest data helped reinforce the "overlapping" treatment possibilities for diabetes, cardiovascular and renal disease. 

"This has the ability to transform the treatment of chronic kidney disease," she said. 

Farxiga was placed under fast-track review by the FDA in August 2019, and AZ plans to file for review with international regulators.