The FDA hands Farxiga 'breakthrough' status in CKD, clearing path for AstraZeneca's much-touted therapy

AstraZeneca has been promising big things on Farxiga in kidney disease since March, when they stopped a Phase III trial over what they deemed “overwhelming efficacy.” R&D chief Mene Pangalos said it had the “potential to change the management of chronic kidney disease for patients around the world.”

Now, with detailed data from that study out, the FDA has signaled it agrees with that assessment. They’ve handed the drug a breakthrough designation to treat patients with chronic kidney disease, regardless of whether they have type 2 diabetes — the original disease for which Farxiga was approved back in 2014.