AstraZeneca said that Forxiga (dapagliflozin) has secured approval in China for its use in the reduction of the risk of cardiovascular (CV) death and hospitalization for heart failure (hHF) in adults having heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF).
The approval for the sodium-glucose co-transporter 2 inhibitor (SGLT2 inhibitor) from the Chinese National Medical Products Administration (NMPA) has been driven by positive data from the phase 3 DAPA-HF trial. It has been indicated for the patient population with and without type-2 diabetes.
In the DAPA-HF clinical trial, Forxiga plus standard of care comprising an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), was shown to have cut down the risk of the composite of CV death or worsening of HF events, including hHF compared to placebo by 26%.
Besides, the two components of the primary composite endpoint were shown to have delivered benefit to the overall effect in the late-stage trial.
Forxiga (branded as Farxiga in the US) has approval in the US, Europe, Japan and other countries for the treatment of HFrEF in adults.
Mene Pangalos – Executive Vice President of AstraZeneca BioPharmaceuticals R&D said: “There is no known cure for chronic heart failure except for heart transplantation, which is why there is an urgent need for new treatment options that can improve symptoms and help patients live longer.
“This approval marks another important step forward in our ambition to improve outcomes for millions of people worldwide living with this life-threatening disease.”