The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga (dapagliflozin; AstraZeneca) to reduce the risk of cardiovascular (CV) death or worsening of heart failure (HF) in adults with HF with reduced ejection fraction (HFrEF) with and without type 2 diabetes.
The sNDA was based on data from the landmark phase 3, randomized, double-blind, placebo-controlled DAPA-HF trial that evaluated the efficacy of dapagliflozin plus standard of care therapy for the prevention of CV death or reduction of HF events (N=4744). The primary composite outcome was the time to first occurrence of CV death or worsening HF (hospitalization or an urgent visit resulting in intravenous therapy for HF).
Results showed that compared with placebo, treatment with dapagliflozin was associated with a reduction in the risk of CV death or worsening HF (primary composite outcome occurred in 386 patients treated with dapagliflozin over a median of 18.2 months vs 502 patients in the placebo arm [hazard ratio (HR), 0.74; 95% CI, 0.65 to 0.85; P <.001]). Similar findings were observed in patients with or without diabetes.
Mene Pangalos, Executive VP, BioPharmaceuticals R&D, said: “Farxiga is well established in the treatment of type 2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure.”
Farxiga, a sodium-glucose cotransporter (SGLT2) inhibitor, is already indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus; and to reduce the risk of hospitalization for HF in adults with type 2 diabetes mellitus and established CV disease or multiple CV risk factors.
A Prescription Drug User Fee Act (PDUFA) date is scheduled for the second quarter of 2020.
For more information visit astrazeneca-us.com.