The Food and Drug Administration (FDA) has granted Fast Track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization in patients with chronic heart failure.
Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is currently being evaluated in the EMPEROR-Reduced (N=3600) and EMPEROR-Preserved (N=5250) phase 3, placebo controlled studies in patients with heart failure with reduced or preserved ejection fraction, respectively. In both trials, the composite primary endpoint is the time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure.
“We eagerly anticipate results from the EMPEROR studies as we advance the development of empagliflozin in this setting,” said Jeff Emmick, MD, PhD, vice president, Product Development, Lilly.
Both trials are estimated to be completed by 2020.
Empagliflozin (Jardiance; Boehringer Ingelheim and Lilly) is currently approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) and also to reduce the risk of cardiovascular death in adult patients with T2DM and established cardiovascular disease.
For more information visit jardiance.com.