Dapagliflozin Receives FDA Approval for Heart Failure, Regardless of Diabetes Status

The FDA has approved dapagliflozin for reducing risk of CV death and hospitalization in patients with HFrEF, regardless of diabetes status.

The US Food and Drug Administration (FDA) has announced the approval of dapagliflozin (Farxiga) to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure with reduced ejection fraction (HFrEF), regardless of diabetes status.

Having already received approval for a similar indication in type 2 diabetics, the SGLT2 inhibitor becomes the first agent in its class to receive approval for treatment of adults with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction, according to a statement from the FDA.

“Heart failure is a serious health condition that contributes to one in eight deaths in the U.S. and impacts nearly 6.5 million Americans,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, in the aforementioned statement. “This approval provides patients with heart failure with reduced ejection fraction an additional treatment option that can improve survival and reduce the need for hospitalization.”

After dominating headlines at major cardiology conferences throughout 2019 and early 2020, dapagliflozin has led the way in reshaping the way cardiologists and endocrinologists view the SGLT2 inhibitor class. With a priority review designation in-hand and backed by data from the landmark DAPA-HF trial, dapagliflozin has the potential to transform treatment algorithms for nondiabetics or diabetics alike.

The 4744-patient DAPA-HF trial compared the impact of dapagliflozin versus placebo on occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with and without type 2 diabetes.

Multiple analyses of DAPA-HF have given cardiologists a view into the real-world impact of dapagliflozin since DAPA-HF’s original release at ESC 2019. From the data presented regarding the SGLT2 inhibitor, investigators were able to determine dapagliflozin exhibited the ability to reduce a composite of total events and time to first event.

The FDA warns of potential adverse effects of using dapagliflozin. These included dehydration and serious UTI and genital yeast infections. The statement also warns elderly patients, those with kidney problems, with low blood pressure, and those on diuretics should be assessed for volume status and kidney function.