AstraZeneca's Farxiga aces kidney disease test—and zooms closer to big new FDA nod
Farxiga secured an FDA fast track in August in chronic kidney disease. (AstraZeneca)
AstraZeneca's Farxiga and Eli Lilly and Boehringer Ingelheim's Jardiance are sparring for the first FDA nod in kidney disease, a potentially huge market. After Jardiance nabbed an FDA priority review earlier this month, Farxiga wouldn't be outdone––and now it could be nearing an approval.
AstraZeneca halted its phase 3 Dapa-CKD trial evaluating Farxiga in chronic kidney disease after interim data "showed Farxiga's benefits earlier than originally anticipated," the drugmaker said in a release Monday.
The primary endpoint of Dapa-CKD was a composite of kidney function worsening or death in patients with or without Type 2 diabetes, AstraZeneca said. In August, the FDA placed Farxiga on fast-track review in CKD based on the trial's findings.
The drugmaker said it would work with global regulators on earlier-than-expected filings and present the details of the data at an upcoming medical meeting.