AstraZeneca's Dapagliflozin (Farxiga) Gains China Approval for Heart Failure Across the Full Spectrum of Ejection Fraction

On August 17, AstraZeneca's dapagliflozin (Farxiga) received approval from the National Medical Products Administration (NMPA) in China for a new indication to treat heart failure with preserved ejection fraction (HFpEF). This approval means that dapagliflozin is now indicated to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure (hHF), and urgent heart failure visits in adult patients. Farxiga was previously approved for use in adults with heart failure with reduced ejection fraction (HFrEF).

This approval was based on the positive results of the Phase III DELIVER trial. The pre-specified pooled analysis results of the DELIVER and Phase III DAPA-HF trials also confirmed that dapagliflozin is the first heart failure treatment drug capable of reducing mortality across the full range of ejection fractions.

DELIVER Study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial that enrolled 6,263 patients, aiming to evaluate the efficacy of dapagliflozin in reducing cardiovascular (CV) death or heart failure (HF) worsening in HFpEF patients. The primary composite endpoint is the time to the first occurrence of an HF event (HF hospitalization or urgent HF visit) or CV death.

Results showed that during a median follow-up of 2.3 years, the incidence of HF events or CV death was significantly reduced in the dapagliflozin group (16.4%, 512 cases) compared to the placebo group (19.5%, 610 cases) (HR, 0.82; 95% confidence interval, 0.73-0.92; p<0.001). The results were published on August 27, 2022, in the NEJM and Nature Medicine journals.

Source: NEJM Journal

Heart failure is a long-term chronic disease that worsens over time. It affects approximately 64 million people globally and has an extremely high incidence and mortality rate. Chronic heart failure is the leading cause of hospitalization for patients over 65 years old, imposing a significant clinical and economic burden. Heart failure can be classified based on left ventricular ejection fraction (LVEF), which is the percentage of blood pumped out of the heart with each contraction, into three categories: heart failure with reduced ejection fraction (LVEF ≤40%), heart failure with mildly reduced ejection fraction (LVEF between 41% and 49%), and heart failure with preserved ejection fraction (LVEF ≥50%). About half of all heart failure patients fall into the categories of mildly reduced or preserved ejection fraction, for which there are very few treatment options available.

Dapagliflozin has been approved in more than 100 regions worldwide, including the United States, the European Union, China, and Japan, for the treatment of patients with type 2 diabetes (T2D), HFrEF, and chronic kidney disease (CKD). Recently, it received regulatory approval in countries such as the United States, the United Kingdom, and Japan to expand its heart failure indication to patients across the full range of ejection fractions.

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