The drugmaker claims that Forxiga is the first SGLT2 inhibitor approved in China to treat heart failure with a reduced ejection fraction
Forxiga approved in China. (Credit: Miguel Á. Padriñán from Pixabay.)
AstraZeneca has secured China’s National Medical Products Administration (NMPA) approval for its oral SGLT2 inhibitor Forxiga (dapagliflozin) to treat a type of heart failure (HF).
The drug is indicated to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF).
HF is a chronic disease that prevents the heart from pumping an adequate amount of blood to different organs in the body.
Almost half of HF patients have a reduced ejection fraction (rEF), which occurs when the left ventricle muscle fails to contract, resulting in less oxygen-rich blood supplied into the body.
Forxiga is known as Farxiga in the US and is approved in the US, Europe, Japan and many other countries, for the treatment of HFrEF in adults.
AstraZeneca BioPharmaceuticals R&D executive vice president Mene Pangalos 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.”
The Chinese regulatory approval follows NMPA’s Centre for Drug Evaluation granting DAPA-HF priority review in May 2020.
The NMPA approval of Forxiga is based on positive results from the Phase 3 Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial.
DAPA-HF is an international, multi-centre, parallel-group, randomised, double-blinded clinical trial in 4,744 patients with heart failure and reduced ejection fraction.
The clinical trial evaluated the effect of Forxiga 10mg, compared with placebo, given once daily in addition to standard of care comprising an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB).
The primary composite endpoint was time to the first occurrence of a worsening heart failure event, including hospitalisation or equivalent event, or cardiovascular death.
Forxiga reduced the risk of the composite of CV death or worsening of HF events, including hHF versus placebo by 26%, meeting both components of the primary composite endpoint.
The company claimed that Forxiga is the SGLT2 inhibitor to show the reduction in CV death or worsening of HF events.
Furthermore, Forxiga’s safety profile in Phase 3 DAPA-HF trial was consistent with the well-established safety profile of the medicine.
Phase 3 DAPA-HF trial investigator Junbo Ge said: “The mortality rate of cardiovascular disease far exceeds that of cancer and other diseases, making it a leading cause of death in China.
“The DAPA-HF trial enrolled Chinese patients from 30 sites. Its results and today’s approval will support a new standard of care for the millions of people in China living with heart failure.”
In December 2020, the company has received Japanese regulatory approval for Forxiga to treat patients with chronic heart failure (HF) who are receiving standard of care.