FDA Approves Dapagliflozin for Heart Failure in Patients With Reduced Ejection Fraction


A phase 3 trial showed a statistically significant and clinically meaningful decline in CV death or hospitalization from heart failure with dapagliflozin compared with placebo.

The FDA has approved dapagliflozin (Farxiga, AstraZeneca ) to decrease the risk of cardiovascular (CV) death and hospitalization from heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D).

The approval follows positive results from the phase 3 DAPA-HF trial, in which dapagliflozin showed a statistically significant and clinically meaningful decline in CV death or hospitalization from heart failure compared with placebo.

“The ground-breaking results of the DAPA-HF trial have transformed heart failure therapeutics,” said John McMurray, MD, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK, in a press release. “Today’s approval provides physicians with a completely novel pharmacological approach that greatly improves outcomes for patients with heart failure with reduced ejection fraction.”

Dapagliflozin is the first sodium glucose co-transporter 2 (SGLT2) inhibitor approved by the FDA for treatment of patients with HFrEF (LVEF ≤ 40%). Earlier this year, dapagliflozin was granted Priority Review designation by FDA and Fast Track designation was granted in September 2019.

In the DAPA-HF trial, researchers found that dapagliflozin, in addition to standard of care, decreased the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% (absolute risk reduction [ARR] = 5% [event rate/100 patient years: 11.6 vs 15.6, respectively]; p<0.0001) in patients with HFrEF, according to a press release. During the trial, the investigators found 1 CV death or hospitalization for HF, or an urgent visit associated with HF could be avoided for every 21 patients treated with dapagliflozin.

The safety profile of dapagliflozin in the DAPA-HF trial was found to be consistent with the previously established profile of the drug in earlier trials. The most common adverse reactions (≥5%) associated with dapagliflozin 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%), which were established in a pool of 12 placebo-controlled studies.

The FDA approved dapagliflozin in October 2019 to reduce the risk of hospitalization for HF in adult patients with T2D and established CV disease or multiple CV risk factors. Dapagliflozin is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. Dapagliflozin is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

“With the approval of Farxiga, we have reached a critical milestone to potentially transform heart failure treatment for the millions of people living with the condition in the US,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, in a press release. “We are now one step closer to making a significant impact on their lives by providing a much-needed treatment to help reduce their disease burden and live longer.”


Farxiga approved in the US for the treatment of heart failure in patients with heart failure with reduced ejection fraction [news release]. London, United Kingdom; May 6, 2020: AstraZeneca website. https://www.astrazeneca.com/media-centre/press-releases/2020/farxiga-approved-in-the-us-for-the-treatment-of-heart-failure-in-patients-with-heart-failure-with-reduced-ejection-fraction.html Accessed May 6, 2020.

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