Forxiga approved in China to reduce the risk of cardiovascular death and hospitalisation in adult patients with symptomatic chronic heart failure – AstraZeneca

Forxiga (dapagliflozin) from AstraZeneca. has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF. Forxiga has previously been approved in China for HF patients with reduced ejection fraction (HFrEF) meaning that Forxiga is now approved in China to reduce the risk of cardiovascular death and hospitalisations in adult patients with symptomatic chronic HF regardless of ejection fraction phenotype.

The approval by China’s National Medical Products Administration (NMPA) is based on positive results from the DELIVER Phase III trial. Results from the prespecified pooled analysis of DELIVER and DAPA-HF Phase III trials also established dapagliflozin as the first HF medication to demonstrate a mortality benefit across the full ejection fraction range.

Heart Failure is a complex syndrome that occurs when the heart cannot pump enough blood around the body. HF affects approximately 4.5 million people in China. Around half of HF patients die within five years of diagnosis. Patients with ejection fraction above 40% are at greater risk of death and hospitalisation and experience an especially high burden of symptoms and physical limitations, and consequently have a poor quality of life. The economic burden of HF in China is huge in terms of healthcare costs and resource utilisation, and hospitalisation is the major contributor to the HF treatment burden – the mean hospital stay for HF patients is 30 days in one year.