AstraZeneca receives China’s NMPA approval for Forxiga
2023-08-21
上市批准临床3期
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来源: Pharmaceutical Technology
AstraZeneca’s Forxiga is indicated for treating individuals with chronic kidney disease, type 2 diabetes and HFrEF in more than 100 countries globally. Credit: AstraZeneca.
AstraZeneca has received approval from China’s National Medical Products Administration (NMPA) for Forxiga (dapagliflozin) to reduce the risk of cardiovascular mortality, hospital admission for heart failure (HF), or urgent HF visits.
The treatment is indicated for usage in adult patients with symptomatic chronic HF.
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The latest development is based on positive data from the Phase III DELIVER clinical trial.
Based on data from the pooled analysis of the Phase III DELIVER and DAPA-HF trials, dapagliflozin is the first HF therapy to show a mortality benefit in complete ejection fraction ranges.
Forxiga can now be used in the region for adults with symptomatic chronic HF, irrespective of their ejection fraction status.
AstraZeneca executive vice-president and biopharmaceuticals business unit president Ruud Dobber stated: “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.”
In February 2023, the European Commission approved Forxiga to treat symptomatic chronic HFrEF.
Forxiga is an oral, once-a-day human sodium-glucose co-transporter 2 (SGLT2) inhibitorsodium-glucose co-transporter 2 (SGLT2) inhibitor.
It is indicated for treating individuals with chronic kidney disease, type 2 diabetes and HFrEF in more than 100 countries globally.
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