FDA Gives Priority Review to AstraZeneca’s Farxiga for CKD
The FDA has granted AstraZeneca’s Farxiga (dapagliflozin) a Priority Review for treating new or worsening chronic kidney disease in adults with and without type 2 diabetes.
The priority review was based on data from a phase 3 trial that showed the drug, alongside the standard of care (an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker), reduced the risk of worsening renal function or cardiovascular or renal death by 39 percent compared to placebo. Additionally, it reduced the risk of death from any cause by 31 percent.
The late-stage trial found that the safety and tolerability of the drug was consistent with its well-established safety profile, AstraZeneca said.