In this revision, the description related to 'left ventricular ejection fraction' in the 'Precautions related to Indications' for the approved chronic heart failure was deleted, and its concerned information was added.
The main revisions are as follows: The description 'Safety and efficacy of Forxiga have not been established for the treatment of chronic heart failure with preserved left ventricular ejection fraction, and therefore, it should be administered to patients with reduced chronic heart failure' In the item of ''Precautions related to Indications' was deleted.
The results of the global Phase III trial (DELIVER trial) in patients with chronic heart failure with preserved left ventricular ejection fraction were added to the 'Clinical Studies' section.
These revisions have been made based on the results of the DELIVER trial described above. This revision of the electronic package insert allows Farxiga to be used as a treatment of patients with chronic heart failure regardless of left ventricular ejection fraction.
The currently approved indications of Forxiga in
About Heart Failure
Heart Failure (HF) is a chronic, long-term condition that worsens over time1. It affects nearly 64 million people globally2 and is associated with substantial morbidity and mortality3. Chronic HF is the leading cause of hospitalisation for those over the age of 65 and represents a significant clinical and economic burden4. There are several types of HF often defined by left ventricular ejection fraction (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%)5. Approximately half of all HF patients have HFmrEF or HFpEF, with few therapeutic options available5, 6.
About DELIVER Trial7,8
DELIVER trial was an international, randomised, double-blind, parallel-group, placebo-controlled, event-driven Phase III trial designed to evaluate the efficacy of Forxiga, compared with placebo, in the treatment of heart failure (HF) patients with left ventricular ejection fraction (LVEF) greater than 40%, with or without type 2 diabetes mellitus. Forxiga 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)7. DELIVER trial is the largest clinical trial to date in HF patients with LVEF above 40%, with 6,263 randomized patients7.
The primary composite endpoint was the time to first occurrence of CV death, hospitalization due to HF (hHF) or an urgent HF visit. Key secondary endpoints include the total number of HF events (hHF or urgent HF visit) and CV death, change from baseline in the total symptom score of the KCCQ at eight months, time to the occurrence of CV death and time to the occurrence of death from any cause7.
About Forxiga
Forxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor. Research has shown Forxiga's efficacy in preventing and delaying cardiorenal disease, while also protecting the organs - important findings given the underlying links between the heart, kidneys and pancreas. Damage to one of these organs can cause the other organs to fail, contributing to leading causes of death worldwide, including type 2 diabetes (T2D) mellitus, heart failure and chronic kidney disease (CKD).
Forxiga is approved in adults and children aged 10 years and above (adults only approved in
Cardiovascular, Renal and Metabolism (CVRM), part of BioPharmaceuticals, forms one of
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