AstraZeneca’s type 2 diabetes[1] drug Farxiga (dapagliflozin) has been in the news a lot lately. A few weeks, ago, the pharmaceutical company halted a trial of the drug[2] in people with chronic kidney disease (CKD)[3] because of an “overwhelming” benefit seen in preliminary results — a sign that the drug is likely to be approved by the U.S. Food and Drug Administration (FDA) for treating CKD, regardless of diabetes status, in the near future.
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Then a few days ago, we described another study[5] showing that SGLT2 inhibitors[6] — a group of type 2 diabetes drugs that includes Farxiga as well as Jardiance (empagliflozin) and Invokana (canagliflozin) — help protect against severe kidney problems in people with diabetes, especially those who already have CKD. SGLT2 inhibitors work by making your kidneys excrete more glucose in your urine, which helps lower blood glucose levels.
Now, Farxiga has been approved by the FDA to treat heart failure with reduced ejection fraction (HFrEF). This type of heart failure is defined by an ejection fraction — a measure of how much blood the heart’s left ventricle pumps out with each heartbeat — of less than 40%.
As noted in a press release[7] from AstraZeneca, this approval is based on a study showing that the drug reduced hospitalization for heart failure, as well as death from cardiovascular causes, in a significant and clinically meaningful way compared with a placebo (inactive pill) in people with HFrEF.
Compared with a placebo, and in combination with standard of care, Farxiga was found to reduce the combined risk of worsened heart failure and death from cardiovascular causes by 26%. For every 21 trial participants with HFrEF, one hospitalization or urgent medical visit for heart failure, or death from cardiovascular causes, could be avoided by taking Farxiga. In light of these results, the Farxiga was given priority review by the FDA earlier this year.
According to the press release, the safety profile of Farxiga for treated HFrEF, as shown in the study, is consistent with its established record in treating type 2 diabetes. Farxiga was approved by the FDA in October 2019 for reducing the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease. The new approval extends the drug’s reach for heart failure beyond people with diabetes.
“With the approval of Farxiga, we have reached a critical milestone to potentially transform heart failure treatment for the millions of people living with the condition in the U.S.,” said Mene Pangalos, executive vice president of BioPharmaceuticals R&D, in the press release. “We are now one step closer to making a significant impact on their lives by providing a much-needed treatment to help reduce their disease burden and live longer.”
Want to learn more about keeping your heart healthy with diabetes? Read “Lower Your Risk of Heart Disease,”[8] “Tips for a Healthy Heart”[9] and “Fight Off Heart Disease With These Five Heart-Healthy Foods.”[10]
Source URL: https://www.diabetesselfmanagement.com/news-research/2020/05/18/farxiga-heart-failure-approval/
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