Dapagliflozin is approved in the EU for the treatment of symptomatic chronic heart failure

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

The European Commission's approval follows positive feedback from the Committee on Medicinal Products for Human Use in December 2022 and is based on the positive results of the DELIVER Phase III trial. The results of the pre-specified pooled analysis of the DELIVER and DAPA-HF Phase III trials also established dapagliflozin as the first heart failure treatment to reduce mortality in the full ejection fraction range.

Heart failure is a long-term chronic condition that worsens over time, affecting around 1500 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 sparing heart failure not only face a higher risk of death and hospitalization, but also have a large burden of symptoms and limited activity, and a poor quality of life.

Because signs and symptoms of mildly reduced ejection fraction and sparing heart failure are often nonspecific and overlap with other clinical symptoms, diagnostic rates are also severely inadequate. Symptoms are often complicated by a variety of interrelated conditions, particularly coronary heart disease, obesity, diabetes, long-term hypertension, and chronic kidney disease (CKD), highlighting the importance of risk management for patients with these complex syndromes.

Dapagliflozin is approved in more than 100 locations around the world, including the United States, the European Union, China, and Japan, for the treatment of patients with type 2 diabetes mellitus (T2D), heart failure with reduced ejection fraction, and chronic kidney disease. Recently, it received regulatory approvals in the UK, Japan and Turkey to extend the heart failure indication to patients in the full ejection fraction range. Applications for heart failure indications extension are currently being reviewed in the United States and other countries.