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. 


Using AI and RWD to Uncover Rare Disease Insights, Accelerate Commercialization and Improve Patient Outcomes

Wednesday, March 24 | 2pm ET / 11am PT

Learn how transformed real world data into real world insights to assist Audentes in their development of AT132 for the treatment of XLMTM. The session reviews how IPM.ia and Audentes collaborated to uncover the XLMTM patient population.

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.

RELATED: Lilly and Boehringer's Jardiance, chasing AZ, nabs speedy FDA review in kidney disease