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AstraZeneca’s supplemental New Drug Application for dapagliflozin (Farxiga) has been granted Priority Review by the FDA.
Officials with the FDA have granted Priority Review to AstraZeneca’s dapagliflozin (Farxiga) for a new indication in patients with heart failure with reduced ejection fraction (HFrEF), according to a press release.1
The new indication would expand dapagliflozin’s use to reduce the risk of cardiovascular (CV) death or the worsening of HF in adults with HFrEF with and without type 2 diabetes. Dapagliflozin was approved in October 2019 for the reduction of hospitalization due to HF in adults with type 2 diabetes and established CV disease or multiple CV risk factors.1
AstraZeneca’s supplemental New Drug Application is based on data from the phase 3 DAPA-HF trial, which were published in The New England Journal of Medicine.
Th study assigned 4744 patients with New York Heart Association class II, III, or IV HF and an ejection fraction of 40% or less to receive either dapagliflozin (10 mg dose once daily) or placebo, in addition to recommended therapy.2
According to the results, over the median of 18.2 months, 16.3% of patients in the dapaliflozin group and 21.2% in the placebo group experienced incidence of the composite outcome of worsening HF or CV death (hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001).2
The findings included:2
Outcomes observed in patients with diabetes were similar to those in patients without diabetes, according to the study.2
“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,” Mene Pangalos, executive vice president, Bio Pharmaceuticals R&D, said in a statement.1 “If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure.”
The FDA previously granted Fast Track designation for the development of dapagliflozin in HF in September 2019. Last August, dapagliflozin also received Fast Track designation for use in delaying the progression of renal failure and prevention of CV and renal death in patients with chronic kidney disease, with and without type 2 diabetes.1
Dapagliflozin is not recommended for patients with type 1 diabetes for the treatment of diabetic ketoacidosis, according to AstraZeneca.1