FDA Approves AstraZeneca’s Kidney Disease Treatment

Pharmaceutical Technology Editors

FDA has approved AstraZeneca’s Farxiga (dapagliflozin) for treating chronic kidney disease in the United States.

AstraZeneca announced on April 30, 2021 that its sodium-glucose cotransporter 2 (SGLT2) inhibitor, Farxiga (dapagliflozin), was approved by FDA for use in the United States to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease (ESKD), cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease (CKD) at risk of progression.

The approval was based in positive results from the DAPA-CKD Phase III trial, which showed that Farxiga, in combination with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function, onset of ESKD, risk of CV, and renal death by 39%, AstraZeneca said in a company press release. The drug also underwent a DECLARE-TIMI 58 Phase III trial which demonstrated that Farxiga is also likely to be effective in patients with less advanced CKD.

“Today’s approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years,” said Mene Pangalos, executive vice-president, BioPharmaceuticals R&D, AstraZeneca. “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 US.”

Source: AstraZeneca