The AstraZeneca drug is the first SGLT2 inhibitor approved for chronic kidney disease regardless of whether the patient has diabetes.
AstraZeneca’s blockbuster type 2 diabetes Farxiga (dapagliflozin) snagged a new indication for patients with chronic kidney disease at risk of progression with or without type 2 diabetes
The medication, which boasted a sales increase of 54% to $625 million in the first quarter of 2021, is now approved 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 chronic kidney disease (CKD) at risk of progression with or without T2D.
The approval is “the most significant advancement in the treatment of chronic kidney disease in more than 20 years,” said Mene Pangalos, executive vice president, of AstraZeneca’s BioPharmaceuticals R&D, in a press release. “We’ve shown impressive efficacy for Farxiga in type 2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease and we are thrilled to be able to bring this medicine to millions of patients in the U.S.”
FDA’s approval was based on positive Phase 3 trial results, which demonstrated that Farxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function, onset of ESKD, or risk of CV or renal death by 39%, compared to placebo in patients with CKD Stages 2-4 and elevated urinary albumin excretion.
The absolute risk reduction was 5.3% over the median time of 2.4 years. Farxiga also significantly reduced the relative risk of death from any cause by 31% compared to placebo, AstraZeneca said.
“Based on the unprecedented results of the DAPA-CKD trial, dapagliflozin is now the first SGLT2 [sodium glucose co-transporter 2] inhibitor approved for the treatment of chronic kidney disease, regardless of diabetes status. This transformational milestone provides patients and physicians with a new and effective treatment option for this often debilitating and life-threatening disease,” said Professor Hiddo L. Heerspink with the University Medical Center Groningen, the Netherlands, co-chair of the DAPA-CKD trial and its executive committee.