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US FDA Approved Empagliflozin


The U.S. FDA Approved Empagliflozin for Wider Range of Patients with Heart Failure



On February 24, 2022, The U.S. FDA approved an expanded indication for empagliflozin which is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, to reduce the risk of Cardiovascular (CV) death and Heart failure (HF) hospitalization in adults with HF with reduced or preserved ejection fraction.

Empagliflozin was originally approved by the FDA in 2014 to improve glucose control for adults with type 2 diabetes. In August, 2021, the FDA approved empagliflozin to reduce risk for CV death and HF hospitalization in adult patients with heart failure reduced ejection fraction (HFrEF), regardless of whether they have diabetes.

New FDA approval means these demonstrated beneficial outcomes can now help to address a significant unmet need for the approximately 3 million adults in the U.S. with HF-pEF, which is a type of heart failure with preserved ejection fraction that has very limited treatment options.

Key points:
  • Empagliflozin is the first and only heart failure treatment which demonstrates a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction.
  • FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. with heart failure with preserved ejection fraction, which has been classified as “the single largest unmet need in cardiovascular medicine”.
  • Heart failure represents a significant, growing disease burden in the U.S., with more than 8 million cases expected by 2030.


Heart failure is a syndrome in which the heart is not meeting the needs of the body, affecting more than six million people in the U.S. Despite therapies in different drug classes, mortality-rate is high and treatment options for a broader range of patients are needed. Symptoms of heart failure vary but can include fatigue, shortness of breath, and swelling in the legs. Heart failure becomes more common with age and is the leading cause of hospitalization in people over 65 years old.

Just six months ago, empagliflozin was approved to reduce the risk of cardiovascular death and hospitalization for one type of heart failure which was heart failure with reduced ejection fraction (HF-rEF); recent decision expands this indication to adults with heart failure. As a result, the indication now includes adults with heart failure with preserved ejection fraction (HF-pEF).

For this new approval, empagliflozin’s outcomes were evaluated as an adjunct to standard of care therapy in a randomized, double-blind, international trial comparing 2,997 participants who received empagliflozin, 10 mg, once daily to 2,991 participants who received the placebo. The main efficacy measurement was the time to death from cardiovascular causes or need to be hospitalized for HF. Of the individuals who received empagliflozin for an average of about two years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared to 17% of the participants who received the placebo. This benefit was mostly attributable to fewer patients being hospitalized for heart failure.

The side effects in clinical studies for patients with HF were generally consistent with side effects in diabetic patients; the most common side effects were urinary tract infections and female fungal infections.


Consequently, the new FDA approval leads to consider Parsian pharmaceutical Co.’s product ” Empagliflozin ” as a better choice for helping different group of patients.

You can also obtain more information about SGLT2 inhibitors in Parsian pharmaceutical Co.’s recent article.


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