News | January 07, 2020

Dapagliflozin Granted FDA Priority Review for Heart Failure With Reduced Ejection Fraction

The U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) from AstraZeneca and granted priority review for dapagliflozin (Farxiga) 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 and without type 2 diabetes (T2D).

January 7, 2020 — The U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) from AstraZeneca and granted priority review for dapagliflozin (Farxiga) 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 and without type 2 diabetes (T2D).

The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.

The sNDA was based on results from the landmark Phase III DAPA-HF trial published in September 2019 in The New England Journal of Medicine, which showed dapagliflozin on top of standard of care reduced the incidence of the composite outcome of CV death or the worsening of HF versus placebo. Dapagliflozin is not indicated to reduce the risk of hospitalization for heart failure (hHF) in patients without diabetes, or to reduce the risk of CV death.

If cleared by the FDA, dapagliflozin will be the first medicine of its kind indicated to treat this population of patients with heart failure.

In September 2019, the FDA granted Fast Track designation for the development of FARXIGA 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 prevent CV and renal death in patients with chronic kidney disease, with and without T2D.

Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. In October 2019, the FDA also approved Farxiga to reduce the risk of hospitalization for heart failure in patients with T2D and established cardiovascular disease or multiple CV risk factors.

 

Related Content

News | Heart Failure

August 8, 2022 — A major risk factor for diabetes, insulin resistance occurs when the cells of the body do not respond ...

Home August 08, 2022
Home
News | Heart Failure

August 5, 2022 — For people with coronary heart disease, beta-blockers can improve survival and quality of life, while ...

Home August 05, 2022
Home
News | Heart Failure

July 27, 2022 — The world’s first HIV-positive to HIV-positive heart transplant has been successfully performed at ...

Home July 27, 2022
Home
News | Heart Failure

July 27, 2022 — Researchers from RCSI University of Medicine and Health Sciences have developed a new lab-based model of ...

Home July 27, 2022
Home
News | Heart Failure

July 20, 2022 — Sequana Medical NV, a pioneer in the treatment of drug-resistant fluid overload in liver disease and ...

Home July 20, 2022
Home
News | Heart Failure

July 15, 2022 — The American Heart Association, the leading voluntary organization devoted to longer, healthier lives ...

Home July 15, 2022
Home
News | Heart Failure

July 13, 2022 — Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today ...

Home July 13, 2022
Home
News | Heart Failure

July 12, 2022 — Pesticides and heavy metals in soil may have detrimental effects on the cardiovascular system, according ...

Home July 12, 2022
Home
News | Heart Failure

July 7, 2022 — Tenaya Therapeutics, Inc., a biotechnology company with a mission to discover, develop and deliver ...

Home July 07, 2022
Home
News | Heart Failure

June 29, 2022 — A spiral wave of electrical activity in the heart can cause catastrophic consequences. One spiral wave ...

Home June 29, 2022
Home
Subscribe Now