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

NIVAHF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients

NIVAHF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients.

News | Heart Failure | June 15, 2021
June 15, 2021 — VoluMetrix, a Nashville-based biotech startup dedicated to creating a new wave of solutions for vital
The Aortix intra-aortic axial flow pump offers hemodynamic support to relieve some of the heart’s workload, allowing the heart to recover while more effectively pushing blood flow to the kidneys.

The Aortix intra-aortic axial flow pump offers hemodynamic support to relieve some of the heart’s workload, allowing the heart to recover while more effectively pushing blood flow to the kidneys.

News | Heart Failure | June 07, 2021
June 7, 2021 – Cardiologists at Hen...
RAFT-AF study showed type of heart failure may influence treatment strategies for heart rate management vs. arrhythmia control in in patients with heart  heart and atrial fibrillation. #ACC21 #ACC2021

RAFT-AF study showed the type of heart failure may influence treatment strategies for heart rate management vs. arrhythmia control in in patients with heart heart and atrial fibrillation. Getty Images

News | Heart Failure | May 19, 2021
May 19, 2021 — Among patients with both ...
The results of the GALACTIC-HF trial shows omecamtiv mecarbil offers benefits to severe heart failure patients. #ACC21 #ACC2021 #GALACTICHF

The results of the GALACTIC-HF trial shows omecamtiv mecarbil offers benefits to severe heart failure patients.

News | Heart Failure | May 18, 2021
May 18, 2021 — The experimental heart failure drug omecamtiv mecarbil reduced heart failure hospitalizations by a gre
The combination heart failure drug sacubitril/valsartan did not significantly reduce the rate of heart failure or cardiovascular death following a heart attack compared to ramipril, an angiotensin converting enzyme (ACE) inhibitor. #ACC21 #ACC2021

The combination heart failure drug sacubitril/valsartan did not significantly reduce the rate of heart failure or cardiovascular death following a heart attack compared to ramipril, an angiotensin converting enzyme (ACE) inhibitor.

News | Heart Failure | May 15, 2021
May 15, 2021 — The combination heart failure drug sacubitril/valsartan (Entresto) did not significantly reduce the ra
Patients hospitalized with COVID-19 may be at risk of developing heart failure even if they do not have a previous history of heart disease or cardiovascular risk factors, a new Mount Sinai study shows. 

Getty Images

News | Heart Failure | May 11, 2021
May 11, 2021 — Patients hospitalized with COVID-1...
Racism and heart disease. This study looks at heart failure patients and the impact of socioeconomic disparities associate with epigenetics. The study looks to overcome preconcieved ideas about race in cardiac studies by looking at underlaying causes for the disease. Image courtesy of the American Journal of Physiology

Image courtesy of the American Journal of Physiology.

News | Heart Failure | April 26, 2021
April 26, 2021 – Cardiovascular diseases are the leading cause of death in the United States.
PA pressure-guided heart failure management is fast becoming the standard of care in NYHA Class III patients. The Cordella Pulmonary Artery Pressure Sensor enables clinicians to remotely monitor and proactively adjust therapy and medications remotely without the need for office visits.

PA pressure-guided heart failure management is fast becoming the standard of care in NYHA Class III patients. The Cordella Pulmonary Artery Pressure Sensor enables clinicians to remotely monitor and proactively adjust therapy and medications remotely without the need for office visits.

News | Heart Failure | March 24, 2021
March 24, 2021 — Endotronix Inc., a digital health and medical technology company working on advancements in treating
Impulse Dynamics Optimizer Smart device is an implantable device that helps optimize cardiac pumping action in heart failure patients.

Impulse Dynamics Optimizer Smart device is an implantable device that helps optimize cardiac pumping action in heart failure patients.

News | Heart Failure | March 03, 2021
March 3, 2021 — Impulse Dynamics recently announced that...
LVAD patient Richard Huggins with the external control and power unit for his new EvaHeart2 left ventricular assist device at Penn State Health's Hershey Medical Center. 

LVAD patient Richard Huggins with the external control and power unit for his new EvaHeart2 left ventricular assist device at Penn State Health's Hershey Medical Center. 

News | Heart Failure | March 02, 2021
March 2, 2021 — P...