9/3/2023 0 Comments Gen 4 ejectorFarxiga was given once daily in addition to background therapy (regional SoC for all comorbidities, including diabetes and hypertension, with the exception of concomitant use of a sodium-glucose cotransporter 2 (SGLT2) inhibitor). 6ĭELIVER was an international, randomised, 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. 10 Approximately half of all HF patients have HFmrEF or HFpEF, 5 with few therapeutic options available. 4 There are several types of HF often defined by LVEF, 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%). 9 Chronic HF is the leading cause of hospitalisation for those over the age of 65 and represents a significant clinical and economic burden. 2 It affects nearly 64 million people globally 8 and is associated with substantial morbidity and mortality. HF is a chronic, long-term condition that worsens over time. It has most recently received regulatory approvals in the EU, Great Britain, Japan and Turkey to extend the HF indication to include patients across the full LVEF range. 7įarxiga is approved for the treatment of patients with type-2 diabetes (T2D), HFrEF and chronic kidney disease (CKD) in more than 100 countries around the world including the US, the European Union (EU), China and Japan. The data from the DELIVER Phase III trial, published in The New England Journal of Medicine , showed Farxiga reached a statistically significant and clinically meaningful early reduction in the primary composite endpoint of CV death or worsening HF in patients with HF with HFmrEF or HFpE.F 1 The results from a pre-specified, pooled analysis of the DAPA-HF and DELIVER Phase III trials, published in Nature Medicine, showed that the treatment effect of Farxiga on the composite endpoint of cardiovascular death, hospitalisation for heart failure or urgent heart failure was consistent across the left ventricular ejection fraction (LVEF) range and established Farxiga as the first sodium-glucose cotransporter 2 (SGLT2) inhibitor to demonstrate a mortality benefit. 4 Approximately half of all HF patients have HF with mildly reduced ejection fraction (HFmrEF) or HF with preserved ejection fraction (HFpEF) 5 and these patients are not only at greater risk of death and hospitalisations but experience an especially high burden of symptoms and physical limitations, and a poor quality of life. 3 It is also the leading cause of hospitalisation for those over 65 years and represents a significant clinical and economic burden. HF is a chronic, long-term condition that worsens over time 2 and affects almost seven million people in the US. The approval of Farxiga in the US 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 heart failure lead healthier lives.” ![]() Ruud Dobber, Executive Vice-President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Approximately half of heart failure patients die within five 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. ![]() ![]() 1 Farxiga was previously approved in the US for adults with HF with reduced ejection fraction (HFrEF). The approval by the Food and Drug Administration (FDA) was based on positive results from the DELIVER Phase III trial. Partnerships, alliances and recognitionĪstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) visits in adults with HF.
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