18th Aug 2023 07:48
(Alliance News) - AstraZeneca PLC on Friday said its drug Forxiga has been approved in China for some adults to reduce the risk of cardiovascular death and hospitalisation.
The Cambridge-based pharmaceutical company said the approval by China's National Medical Products Administration is for adult patients with symptomatic chronic heart failure. It was previously approved in China for heart failure patients with reduced ejection fraction.
Forxiga is "the first and only heart failure therapy with a proven mortality benefit," AstraZeneca said.
Ruud Dobber, executive vice president & president of AstraZeneca's BioPharmaceuticals Business Unit: 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."
Heart failure affects about 4.5 million people in China.
"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," AstraZeneca said, citing a 2018 study that is among others published in the US's National Center for Biotechnology Information.
Besides treating heart failure, Forxiga is also used to treat type 2 diabetes and chronic kidney disease.
By Tom Budszus, Alliance News reporter
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