9 May 2022 - - High-level results from the DELIVER Phase III trial showed British-Swedish multinational pharmaceutical and biotechnology AstraZeneca's (NASDAQ: AZN) Farxiga (dapagliflozin) reached a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular death or worsening heart failure.

The trial was conducted in patients with HF with mildly reduced or preserved ejection fraction (defined as left ventricular ejection fraction [LVEF] greater than 40%).

HF is a chronic, long-term condition that worsens over time. It affects nearly 64 m people globally and is associated with substantial morbidity and mortality.

There are several main categories of HF related to ejection fraction, a measurement of the percentage of blood leaving the heart each time it contracts including: HF with reduced EF (HFrEF) (LVEF less than or equal to 40%), HF with mildly reduced EF (HFmrEF) (LVEF 41-49%) and preserved EF (HFpEF) (LVEF greater than or equal to 50%).

Approximately half of all HF patients have mildly reduced or preserved EF with few therapeutic options available.

Farxiga already has approved indications relating to the treatment of type 2 diabetes, HFrEF and chronic kidney disease.

The safety and tolerability profile of Farxiga in the DELIVER Phase III trial were consistent with the well-established safety profile of the medicine.

The full DELIVER Phase III trial results will be submitted for presentation at a forthcoming medical meeting and regulatory submissions will be made in the coming months.

HF affects approximately 64m people worldwide, at least half of whom have a reduced EF6, including approximately 15m in the EU, 6m in the US, and 13.7m treated adults in China.

There are several main categories of HF related to EF, a measurement of the percentage of blood leaving the heart each time it contracts including: HFrEF (LVEF less than or equal to 40%), HFmrEF (LVEF 41-49%) and HFpEF (LVEF greater than or equal to 50%).

HF with EF above 40% represents about half of all HF cases, and is highly prevalent in patients with hypertension, T2D, obesity, metabolic syndrome or CKD.

HF remains as fatal as some of the most common cancers in both men (prostate and bladder cancers) and women (breast cancer).

Chronic HF is a cause of hospitalization for those over the age of 65 and represents a significant clinical and economic burden.

DELIVER was an international, randomized, double-blind, parallel-group, placebo-controlled, event-driven Phase III trial designed to evaluate the efficacy of Farxiga, compared with placebo, in the treatment of HF patients with LVEF greater than 40% with or without T2D.

FARXIGA was given once daily in addition to background therapy (regional standard of care for all comorbidities, including diabetes and hypertension, with the exception of concomitant use of a sodium-glucose cotransporter 2 [SGLT2] inhibitor). 

DELIVER is the largest clinical trial to date in HF patients with EF above 40%, with 6,263 randomized patients.

The primary endpoint was the time to first occurrence of CV death, hospitalization for HF or an urgent HF visit.

The secondary endpoint includes the total number of HF events (hHF or urgent HF visit) and CV death, change from baseline in the total symptom score of the Kansas City Cardiomyopathy Questionnaire at eight months, time to the occurrence of CV death and time to the occurrence of death from any cause.

Cardiovascular, Renal and Metabolism, part of BioPharmaceuticals, forms one of AstraZeneca's main disease areas and is a key growth driver for the company.

By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines for organ protection and improving outcomes by slowing disease progression, reducing risks and tackling co-morbidities.

The company's ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients worldwide.

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal and Metabolism, and Respiratory and Immunology.

Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide.