The US Food and Drug Administration (FDA) has approved AstraZeneca’s Farxiga (dapagliflozin), the first SGLT2 inhibitor, to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with heart failure with reduced ejection fraction (HFrEF).
The approval was granted based on positive results from the Phase III Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial.
In the trial, Farxiga achieved a statistically significant and clinically meaningful reduction of CV death or hospitalisation for heart failure, compared to placebo.
Heart failure is a chronic and degenerative disease responsible for the death of nearly 50% of patients within five years of diagnosis.
Farxiga safety profile in the international, multi-centre, parallel-group, randomised, double-blinded trial was consistent with the well-established safety profile of the medicine.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “With the approval of Farxiga, we have reached a critical milestone to potentially transform heart failure treatment for the millions of people living with the condition in the US.
“We are now one step closer to making a significant impact on their lives by providing much-needed treatment to help reduce their disease burden and live longer.”
Last October, the FDA approved Farxiga, based on the DECLARE-TIMI 58 trial, to reduce the risk of hHF in adult patients with type 2 diabetes and established CVD or multiple CV risk factors.
Farxiga is also currently being evaluated to treat patients with chronic kidney disease (CKD) in the Phase III DAPA-CKD trial.
The trial was stopped early after a Data Monitoring Committee determination of overwhelming efficacy.