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.
