AstraZeneca’s Forxiga approved in China for chronic heart failure treatment
AstraZeneca has announced that Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF) or urgent HF hospital visits in adult patients with chronic HF.
Forxiga was already approved in China for HF patients with reduced ejection fraction (HFrEF), meaning the drug is now approved for patients with symptomatic HF regardless of ejection fraction phenotype.
China’s National Medical Products Administration (NMPA) made this decision following positive results from the DELIVER phase 3 trial, results from this combined with analysis of the DAPA-HF phase 3 trial demonstrated the drug’s mortality benefit for all HF patients regardless of ejection fraction.
Ruud Dobber, executive vice president and president of the BioPharmaceuticals Business Unit at AstraZeneca, commented: “This broader indication for Forxiga in adults with symptomatic chronic HF 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.”
The drug is approved for the treatment of patients with T2D, HFrEF and CKD in over 100 countries, including China, Japan, the US and the EU.
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