The US Food and Drug Administration (FDA) has granted AstraZeneca’s Forxiga (dapagliflozin) a priority review for the treatment of new or worsening chronic kidney disease (CKD).
AZ is aiming for approval in adult patients both with and without type 2 diabetes (T2D). In October 2020, Forxiga also received breakthrough therapy designation from the FDA for this indication.
The FDA priority review is based on clinical evidence from the DAPA-CKD trial, which evaluated the drug on top of standard of care – consisting of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) – in patients with CKD stages 2-4 and elevated urinary albumin excretion.
In this trial, Forxiga plus standard of care reduced the risk of the composite of worsening renal function or risk of cardiovascular or renal death by 39% compared to placebo.
The trial was stopped early in March 2020, based on recommendations from an independent data monitoring committee which determined the trial’s ‘overwhelming’ efficacy.
“This decision brings us a step closer to delivering this new treatment option for the millions of patients living with chronic kidney disease in the US,” said Mene Pangalos, executive vice president, biopharmaceuticals R&D, AZ.
“Forxiga has the potential to be a truly transformational medicine across a breadth of diseases, including type 2 diabetes, heart failure with reduced ejection fraction and, if approved, chronic kidney disease,” he added.
Forxiga is approved in the US as an adjunct to diet and exercise to improve glycaemic control in adults living with T2D.
It is also approved to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure with reduced ejection fraction, with and without T2D.