AstraZeneca’s Forxiga (dapagliflozin) has been approved in China to reduce the risk of cardiovascular death, hospitalisation for heart failure (HF), or urgent HF visits in adults with symptomatic chronic HF.
The drug was previously approved in China but was limited to HF patients with reduced ejection fraction (HFrEF).
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.1,2
Ruud Dobber, Executive Vice President, and President BioPharmaceuticals Business Unit, 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.”
HF affects approximately 4.5 million people in China.3 Around half of HF patients die within five years of diagnosis.4 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.5
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.
- Jhund PS, et al. Dapagliflozin across the range of ejection fraction in patients with heart failure: a patient-level, pooled meta-analysis of DAPA-HF and DELIVER. Nat Med. 2022;28(9):1956-64.
- Solomon S, et al. Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med. 2022; 387(12):1089-1098.
- Guo Y, et al. Heart Failure in East Asia. Current Cardiology Reviews. 2013;9:112-122.
- Tsao CW, et al. Heart Disease and Stroke Statistics—2023 Update. Circulation. 2023;147:e93-e621. PMID: 36695182.
- Warraich HJ, et al. Physical function, frailty, cognition, depression, and quality of life in hospitalized adults ≥60 years with acute decompensated heart failure with preserved versus reduced ejection fraction. Circ Heart Fail. 2018;11(11):e005254.
Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World