Forxiga has just been approved by China's National Medical Products Administration. The drug is also approved for the treatment of patients with chronic kidney disease
Forxiga (dapagliflozin) 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.
Ruud Dobber, VP, and President BioPharmaceuticals Business Unit, AstraZeneca, said: “This broader indication for Forxiga in adults with symptomatic chronic heart failure across the full ejection fraction range is a significant advancement for patients. It represents an exciting turning point in the battle against heart failure given the unmet treatment needs and the absence until now of treatments that reduce mortality in this setting."
It represents an exciting turning point in the battle against heart failure given the unmet treatment needs
- Ruud Dobber, VP, and President BioPharmaceuticals Business Unit, AstraZeneca
Dobber continued: "Importantly, this development underscores our commitment to accelerating earlier detection and coordinated care, to address the complexities of heart failure across the disease spectrum.”
HF 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.
Forxiga is also approved for the treatment of patients with T2D, HFrEF and CKD in more than 100 countries around the world including China, Japan, the US, and the EU.