The Prescription Drug User Fee Act date, the FDA action data for this supplemental application, is scheduled for the second quarter of 2020.
The FDA has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for dapagliflozin (Farxiga, AstraZeneca) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with or without type 2 diabetes.
The Prescription Drug User Fee Act’s action date for this application is scheduled for the second quarter of 2020.
The sNDA was based on the results from the phase III DAPA-HF trial published in The New England Journal of Medicine. This study showed dapagliflozin when combined with the standard of care, reduced the incidence of the composite outcome of CV death or the worsening of HF versus placebo.
According to the press release, dapagliflozin is not indicated to reduce the risk of hospitalization for heart failure in patients without diabetes, or to reduce the risk of CV death.
“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,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D, in a prepared statement.
In September 2019, the FDA granted Fast Track designation for the development of dapagliflozin in HF. In August 2019, the FDA also granted Fast Track designation for the development of dapagliflozin to delay the progression of renal failure, and to prevent CV and renal death in patients with chronic kidney disease, with or without type 2 diabetes.
Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. In October 2019, the FDA also approved dapagliflozin to reduce the risk of hospitalization for HF in patients with type 2 diabetes and established CV or multiple CV risk factors.
FARXIGA granted FDA Priority Review for patients with heart failure with reduced ejection fraction [press release]. AstraZeneca website. Published January 6, 2020. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/farxiga-granted-fda-priority-review-for-patients-with-heart-failure-with-reduced-ejection-fraction-01062020.html. Accessed January 6, 2020.