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AstraZeneca’s Forxiga approved in China

Forxiga has been approved in China to reduce the risk of cardiovascular death, hospitalization 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.

“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,” says Ruud Dobber, Executive Vice President, and President BioPharmaceuticals Business Unit, AstraZeneca.

Based on positive results from the DELIVER Phase III trial

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.

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.

Photo of Ruud Dobber: AstraZeneca

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