Forxiga Gains Approval in China for Multiple Cardio-Related Diseases

On February 4th, China’s National Medical Products Administration (NMPA) approved AstraZeneca’s Forxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction.

The approval is based upon the successful DAPA-HF Phase III trial, the results of which are published in The New England Journal of Medicine. The NMPA approval comes after the approvals by the US, EU, and Japan. A month’s supply of Forxiga for heart failure is expected to cost $492, the same as that of diabetes.

“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,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D.

Heart Failure with Reduced Ejection Fraction

Heart failure (HF) is as fatal as both prostate and bladder cancers for men and breast cancer for women. HF is a serious chronic disease that prevents the heart’s left ventricle muscle from pumping blood to provide sufficient oxygen levels throughout the body; such a phenomenon is called reduced ejection fraction (rEF). Among approximately 64 million people worldwide affected by HF, there are 15 million in the EU, six million in the US, and seven million in China.

Forxiga

The idea to research Forxiga stemmed from the continuous evidence of cardiorenal effects having an association between the heart, kidneys, and pancreas. Diseases like type 2 diabetes (T2D), HF, and chronic kidney disease (CKD) cause damage to one of these organs and can sometimes induce other organ failures.

Forxiga is a first-in-class, oral, once-daily SGLT2 (sodium-glucose cotransporter-2) inhibitor, which is comprised of canagliflozin (Invokana), empagliflozin (Jardiance), and ertuliflozin (Steglatro). These drugs are already approved by the FDA to treat T2D by stopping the kidneys from absorbing extra sugar in the urine back into the blood.

DAPA-HF Phase III Trial

DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) is an international, multi-center, parallel-groups, randomized, double-blinded Phase III trial that enrolled 4,744 patients with HFrEF (LVEF < 40%), with and without T2D.

The average age of enrollees was 66 years old, and the number of male participants was 77%, while only 23% were female. The trial was designed to evaluate the effects of 10mg of Forxiga versus placebo, each given once daily in addition to standard of care consisting of an ACEi (angiotensin-converting enzyme inhibitor) or an ARB (angiotensin receptor blocker).

The primary endpoint was time to the first occurrence of a worsening heart failure event like hospitalization and CV death. The median duration of the trial was 18.2 months.

The results demonstrated a 26% reduction of the risk of composite of CV death or worsening of HF events with Forxiga arm. In other words, one CV death, hHF, or an urgent HF visit resulting in intravenous therapy could be avoided for every 21 patients treated with Forxiga. The safety profile of Forxiga was consistent with previous studies.

“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,” said Junbo Ge, Professor, Director and Doctoral advisor in the Department of Cardiology, Zhongshan Hospital, Fudan University, China, and investigator in the trial.

By Judy Ya-Hsuan Lin

Related Article: Spotlight: The Many Facets of AstraZeneca’s Farxiga

References

1. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/forxiga-approved-in-china-for-heart-failure.html?fbclid=IwAR0xMUkJEjc5-5Ub9Mc-K0qCvsG4ayBTT7i_SV9ORhlVxsMTf5dTJWwpJCA

Author

Judy Ya-Hsuan Lin

Success is the ability to go from one failure to another with no loss of enthusiasm.