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Recently, AstraZeneca announced that Andatang (generic name: Dapagliflozin) has been approved in the European Union, expanding the indications for the treatment of heart failure with reduced ejection fraction (HFrEF) to cover the entire left ventricular ejection fraction (LVEF) ) range of patients, including mildly reduced ejection fraction and preserved heart failure (HFmrEF, HFpEF).

The approval by the European Commission is based on the positive results of the DELIVER Phase III trial following the positive feedback from the Committee for Medicinal Products for Human Use in December 2022. The results of the pre-specified pooled analysis of the DELIVER and DAPA-HF phase III trials also established that dapagliflozin is the first heart failure drug that can reduce mortality within the range of full ejection fraction.

Heart failure is a long-term chronic disease that worsens over time and affects around 15 million people in Europe. About half of patients with heart failure die within five years of diagnosis, and patients with mildly reduced ejection fraction and preserved heart failure not only face a higher risk of death and hospitalization, but also have a large burden of symptoms and activity limitations, quality of life Difference.

Because the signs and symptoms of mildly reduced ejection fraction and preserved heart failure are often nonspecific and overlap with other clinical symptoms, they are also severely underdiagnosed. Patients' symptoms are often complicated by multiple interrelated diseases, especially coronary heart disease, obesity, diabetes, long-term hypertension and chronic kidney disease (CKD), highlighting the importance of risk management in patients with these complex syndromes.

Dapagliflozin has been approved in more than 100 regions around the world, including the United States, the European Union, China, and Japan, for the treatment of patients with type 2 diabetes (T2D), heart failure with reduced ejection fraction, and chronic kidney disease. It recently received regulatory approvals in the UK, Japan and Turkey, extending the heart failure indication to patients in the full ejection fraction range. Applications for the expansion of the heart failure indication are currently under review in the US and other countries.