Empagliflozin gains FDA approval as treatment for adult HFrEF patients
Empagliflozin has received FDA approval as a treatment for adult patients with heart failure with reduced ejection fraction (HFrEF).
The SGLT2 inhibitor, sold by Boehringer Ingelheim and Eli Lilly and Company under the name Jardiance, was developed to help patients reduce their risk of cardiovascular death or hospitalization for heart failure. Back in June, empagliflozin was approved in Europe for the same purpose.
The FDA’s decision was based largely on results from the EMPEROR-Reduced trial, which compared empagliflozin with a placebo in more than 3,700 heart failure patients without type 2 diabetes and with a left ventricular ejection fraction of 40% or less.
“Jardiance is already a recognized leader for adults with type 2 diabetes, including those who also have established cardiovascular disease,” Jeff Emmick, MD, PhD, vice president of product development for Eli Lilly and Company, said in a prepared statement. “We’re excited to build on that legacy with this new indication that establishes Jardiance as an effective treatment for adults with heart failure with reduced ejection fraction—regardless of whether they have type 2 diabetes.”
“Today’s FDA approval of Jardiance in heart failure with reduced ejection fraction, which follows authorization for use in the EU by the European Commission in June, marks an important milestone in our journey to help transform care for adults with heart failure,” added Mohamed Eid, MD, MPH, MHA, Boehringer Ingelheim’s vice president of clinical development and medical affairs for cardio-metabolism and respiratory medicine. “We look forward to continuing to investigate the potential benefit of Jardiance across cardio-renal-metabolic conditions.”
Empagliflozin is not recommended for patients with type 1 diabetes due to its potential to “increase the risk of diabetic ketoacidosis in these patients.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.