AstraZeneca's big CKD promises come to fruition as Farxiga wins approval in patients regardless of diabetes status
Almost a year after nabbing a groundbreaking approval for heart failure patients with or without type 2 diabetes, AstraZeneca’s Farxiga claimed another notable OK on Friday.
The SGLT2 inhibitor got the FDA green light for chronic kidney disease in adults at risk of progression, the British pharma said late Friday afternoon. Much like the heart failure approval, Friday’s win is also indicated for patients regardless of if they have type 2 diabetes. Farxiga was originally approved to treat type 2 diabetes back in 2014.
The drug is now the first in its class to treat CKD regardless of diabetes status, a move R&D chief Mene Pangalos hailed in a statement as “the most significant advancement in the treatment of chronic kidney disease in more than 20 years.”
Farxiga has proved to be one of AstraZeneca’s biggest sellers, growing by 30% last year when it totaled nearly $2 billion in sales. Though it hit the market after J&J rival Invokana, Farxiga managed to eat up a large portion of the SGLT2 pie after Invokana was hit with a black box warning for an increased risk of amputation.
The expanded label also puts Farxiga well ahead of Eli Lilly and Boehringer Ingelheim’s competitor Jardiance, which isn’t expected to read out CKD data until next year at the earliest.
AstraZeneca had been drumming up excitement for the drug ever since they wrapped up their CKD trial early in March 2020, when they claimed “overwhelming efficacy.” They followed that up with data in August, which showed Farxiga reduced cardiovascular or renal mortality and the worsening of renal function by 39% compared to placebo. Farxiga also reduced the risk of death from any cause by 31%.
Its dataset proved to be impressive enough to nab the FDA’s breakthrough therapy designation in October, and priority review in January. And exploratory analyses from one of its Phase III studies reportedly showed the drug can be effective in CKD patients with less severe disease, the British drugmaker claimed.
Friday’s approval will open up Farxiga to a market of about 37 million patients in the US, AstraZeneca says.
Though the pharma has anchored a turnaround primarily on its oncology portfolio, CEO Pascal Soriot has long made it a goal to expand Farxiga from diabetes into other diseases. That ambition has largely proven successful over the last two years or so, first with the heart failure approval and now Friday’s CKD win.
Farxiga, like its SGLT2 inhibitor compatriots, works by targeting a protein in the kidneys that affects how the body reabsorbs glucose. By blocking the SGLT2 protein, the drugs lower reabsorption and consequently lower blood sugar levels.
The full indication for CKD allows Farxiga to be used to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalization for heart failure (hHF) in adults with the disease.