FDA Approves Expanded Label for Dapagliflozin to Reduce Risk of Cardiovascular Death, Hospitalization from Heart Failure

FDA Approves Expanded Label for Dapagliflozin to Reduce Risk of Cardiovascular Death, Hospitalization from Heart Failure

The FDA has approved an expanded label for dapagliflozin (Farxiga; AstraZeneca) to include an indication to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure (HF), and urgent HF in adults.

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The approval for the expanded indication was based on positive results from the DELIVER (NCT03619213) phase 3 trial, which was published in The New England Journal of Medicine.

“Approximately half of patients [with HF] die within 5 years of diagnosis, highlighting an urgent unmet need for well-tolerated treatment options that can bring life-saving benefits and reduce the risk of cardiovascular death,” Ruud Dobber, executive vice president of the BioPharmaceuticals Business Unit at AstraZeneca, said in a press release. “The approval of [dapagliflozin] in the [United States] not only reinforces AstraZeneca’s commitment to reducing the burden of this complex and life-threatening disease but will help patients across the full spectrum of [HF] lead healthier lives.”

DELIVER was an international, randomized, double-blind, and placebo-controlled phase 3 trial designed to evaluate the efficacy of dapagliflozin compared to a placebo. The trial randomized 6263 patients with HF with LVEF that was greater than 40%, with or without type 2 diabetes (T2D).

Investigators administered dapagliflozin once a day in addition to background therapy, including regional standard of care for all comorbidities, such as diabetes and hypertension. The only exception included the concomitant use of other sodium-glucose cotransporter 2 inhibitors.

The primary composite endpoint was the time to first occurrence of CV death, hospitalization from HF, or urgent HF visit. The key secondary endpoint included the total number of HF events and CV death, changed from baseline score of the KCCQ at 8 months, time to the occurrence of CV death, and time to the occurrence of death from any cause.

The findings showed that dapagliflozin reached a statistically significant and clinically meaningful early reduction in the composite primary endpoint of CV death or worsening HF in patients who had HF with mildly reduced ejection fraction or HF with preserved ejection fraction.

Additionally, in a pre-specified, pooled analysis of DAPA-HF (NCT03036124) and the DELIVER trials, results showed that the treatment effects of dapagliflozin on the composite endpoint of CV death, hospitalization for HF, or urgent HF was consistent across the LVEF range. Furthermore, dapagliflozin was established as the first SGLT2 inhibitor that demonstrated a mortality benefit. The results from the pooled analysis were published in Nature Medicine.

Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D mellitus; to reduce the risk of hospitalization for HF in adults with T2D mellitus and either established cardiovascular disease (CVD) or multiple CVD risk factors; to reduce the risk of CVD death and hospitalization for HF in adults with HF with reduced ejection fraction; to reduce the risk of sustained estimated glomerular filtration rate decline, end-state kidney disease, cardiovascular death, and hospitalization for HF in adults with CKD at risk of progression.

Dapagliflozin was previously approved in the United States for patients with HF with reduced ejection fraction (HFrEF). It is also approved for the treatment of patients with T2D, HFrEF, and chronic kidney disease in more than 100 countries, including the United States, European Union, China, and Japan.

Recently, it received approvals in the European Union, Great Britain, Japan, and Turkey, which was extended to include those in the full LVEF range.


Farxiga extended in the US to reduce risk of cardiovascular death and hospitalisation for heart failure to a broader range of patients. AstraZeneca. News release. May 9, 2023. Accessed May 9, 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/farxiga-extended-in-the-us-for-heart-failure.html

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