FDA Fast Track designation for SGLT2i in patients with and without T2DM after acute MI

News - Sep. 17, 2020

The US Food and Drug Administration (FDA) has granted Fast Track designation for the SGLT2 inhibitor empagliflozin to prevent heart failure (HF) hospitalization and reduce mortality in patients with and without diabetes, who have had an acute myocardial infarction (MI).

FDA Fast Track designation facilitates development of potential new therapies to treat serious conditions and fulfil an unmet medical need.

In the Streamlined, Multicenter, Randomized, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalization for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction (EMPACT-MI) trial, the effect of empagliflozin on all-cause mortality and hospitalization for HF is investigated in patients with and without T2DM who have had an cute MI and no history of chronic HF. This RCT phase III trial is currently ongoing and results are anticipated in 2023.

Source: press release Lilly, September 15, 2020

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