FDA Approves Dapagliflozin for Heart Failure Across the Full Spectrum of Ejection Fraction

On May 9, AstraZeneca announced that Farxiga (dapagliflozin) has been approved by the U.S. FDA for an expanded indication to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure (hHF), and emergency visits for heart failure in adult patients. Farxiga was previously approved in the U.S. for adult patients 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 that can reduce 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 (hospitalization for HF or urgent HF visit) or CV death.

Results showed that during a median follow-up of 2.3 years, the incidence of heart failure (HF) events or cardiovascular (CV) death was significantly lower 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 findings were published on August 27, 2022, in the New England Journal of Medicine (NEJM) and Nature Medicine.

(Source: NEJM Journal)

Heart failure is a long-term chronic disease that worsens over time. It affects approximately 64 million people worldwide and has extremely high incidence and mortality rates. Chronic heart failure is the leading cause of hospitalization for patients over 65, imposing a significant clinical and economic burden. Heart failure is categorized based on the left ventricular ejection fraction (LVEF), the percentage of blood pumped out of the heart with each contraction, into: 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 have either mildly reduced or preserved ejection fraction, with very limited 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 the UK, Japan, and Turkey to expand its heart failure indication to patients across the full range of ejection fractions.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably quote. When quoting, please clearly indicate the source of the article; if you need to reprint, please leave a message to the WeChat Official Account or send a message, and specify the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Wonderful Live Broadcast

CUBE LIVE

↑ Click to scan the QR code and reserve a live broadcast ↑