AstraZeneca announced that China’s National Medical Products Administration (NMPA) has approved its Forxiga (dapagliflozin) to lower the risk of cardiovascular (CV) death, hospitalisation for heart failure (HF), or immediate HF visits for symptomatic chronic HF patients.

Forxiga is an oral, once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2).

Previously, it was approved in China for HF patients with reduced ejection fraction (HFrEF). The recent approval enables the use of Forxiga regardless of ejection fraction phenotype.

The approval was based on positive results from the DELIVER Phase 3 trial.

According to findings from the predetermined pooled analysis of the DELIVER and DAPA-HF Phase 3 studies, Forxiga was found to be the first HF drug to show a mortality benefit over the complete range of ejection fractions.

In the DELIVER trial, the SGLT2 inhibitor met its primary endpoint in reducing the composite outcome of CV death or worsening HF by 18%.

AstraZeneca BioPharmaceuticals Business Unit EVP and president Ruud Dobber 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.”

DELIVER was a randomised, parallel-group, double-blind, placebo-controlled, event-driven Phase 3 trial.

It had a goal to assess the efficacy of Forxiga against placebo in HF patients’ treatment with left ventricular ejection fraction (LVEF) above 40%, with or without type 2 diabetes (T2D).

DAPA-HF was a multi-centre, randomised, parallel-group, double-blinded Phase 3 trial.

It evaluated the effect of Forxiga 10mg in 4,744 patients with HFrEF, with and without T2D against placebo, given once daily in addition to standard of care.

The primary endpoint was defined as the first occurrence of a worsening HF event, or CV death.

Forxiga is already cleared for the treatment of patients with chronic kidney disease, T2D and HFrEF in around 100 countries, including China, Japan, the US, and the EU.