AstraZeneca's Farxiga gets rough FDA review date for groundbreaking move into chronic kidney disease
AstraZeneca’s Farxiga broke ground last year with an FDA nod for heart failure patients with or without type 2 diabetes — a first-in-class approval. But Farxiga isn’t done innovating and is now looking at a approval in the coming months in another potential blockbuster indication.
The FDA will review AstraZeneca’s application to take SGLT2 inhibitor Farxiga into chronic kidney disease sometime in the second quarter after tagging the drug for priority review, the British drugmaker said Wednesday. CKD is believed to currently affect roughly 37 million US patients, AstraZeneca said.
Three months after designating Farxiga as a breakthrough therapy in CKD patients with or without type 2 diabetes, the FDA will now formally speed its application in that indication for what would be a first-in-class approval. While Johnson & Johnson’s SGLT2 rival Invokana sports an FDA approval in diabetic kidney disease, a potential nod for Farxiga would make it the first SGLT2 on the market for kidney patients without diabetes.
The FDA gave Farxiga the breakthrough tag after outcomes data unveiled in August at the European Society of Cardiology annual meeting showed Farxiga cut the combined risk of worsening kidney function, end-stage kidney disease onset, and kidney disease- or cardiovascular-related death by 39% over placebo in patients with CKD with or without type 2 diabetes.
In what AstraZeneca called “paradigm-shifting” findings, Farxiga’s Dapa-CKD outcomes trial showed the drug also sliced the risk of all-cause mortality by 31% over placebo, a key secondary endpoint. Those results were consistent across patients regardless of whether they had a diabetes diagnosis.
AstraZeneca released its top-line findings in July after halting the trial early in March, when interim data “showed Farxiga’s benefits earlier than originally anticipated,” the drugmaker said at the time.
If Farxiga does cross the finish line in CKD, it would represent a second approval once thought unlikely for a drug class developed for diabetes.
In May, the FDA approved Farxiga to reduce the risk of cardiovascular death or hospitalization in heart failure patients with a reduced ejection fraction (HFrEF) and with or without type 2 diabetes, another first in the SGLT2 class.
Farxiga got the OK to treat roughly six million US HFrEF patients each year, expanding on its earlier FDA approvals to treat heart failure patients with type 2 diabetes and to improve glycemic control in type 2 diabetes patients.
That approval followed an FDA priority review granted in January 2020 and a fast-track designation in September 2019. The drug also sports a fast-track review in heart failure with a preserved ejection fraction (HFpEF) — an indication where Novartis’ Entresto, a combination of sacubitril and valsartan, earned the FDA’s nod in December as a first approved therapy.