AstraZeneca’s Forxiga (dapagliflozin) has been approved in China for use in adults with symptomatic chronic heart failure.
The drug has previously been approved in China for heart failure patients with reduced ejection fraction (HFrEF) meaning that Forxiga is now approved in China 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 results from the DELIVER Phase III trial.
Ruud Dobber, executive vice president, and president of the BioPharmaceuticals Business Unit at 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. Importantly, this development underscores our commitment to accelerating earlier detection and coordinated care, to address the complexities of heart failure across the disease spectrum.”
Forxiga is also approved for the treatment of patients with type 2 diabetes, HFrEF and chronic kidney disease (CKD) in more than 100 countries around the world including China, Japan, the USA, and the EU.