AstraZeneca's Farxiga backs up kidney disease trial stop with new top-line data
AstraZeneca's Farxiga scored a nod in May to treat heart failure in patients with or without Type 2 diabetes. (AstraZeneca)
AstraZeneca has shaken up the lucrative heart failure market with diabetes med Farxiga after a major approval earlier this year. But in kidney disease, another blockbuster market, Farxiga also sports promising data, and it could spell a big FDA nod to come.
Farxiga hit its primary endpoint of decreased kidney function, end-stage kidney disease and cardiovascular death in a pivotal phase 3 trial for patients with chronic kidney disease (CKD), according to top-line data released Tuesday.
The top-line results come months after AstraZeneca halted its Dapa-CKD trial when interim data "showed Farxiga's benefits earlier than originally anticipated," the drugmaker said in March.
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Farxiga not only cut CKD patients' serious risk factors, but the SGLT2 inhibitor also hit its secondary endpoints in patients with or without Type 2 diabetes, including reducing death from any cause, making Farxiga the first medicine to cut the risk of death in that patient population, AstraZeneca said.
The British drugmaker plans to present the full results of the study at an upcoming medical meeting, it said.
A major win in CKD, which is believed to affect 700,000 U.S. patients each year, puts Farxiga in good position to challenge Eli Lilly and Boehringer Ingelheim's Jardiance—which is also chasing a CKD approval—and Johnson & Johnson's Invokana, which already has a kidney disease nod.