Germany-based Boehringer Ingelheim and United States-based Eli Lilly and Company have revealed that The US Food and Drug Administration (FDA) has granted fast track designation to Empagliflozin for the decrease of cardiovascular death and hospitalisation for heart failure in people with chronic heart failure, it was reported yesterday.
The Fast Track designation allows the development of new therapies that complete an unmet medical requirement for serious conditions in an effort to accelerate the availability of new treatment options.
The fast track designation is for the ongoing EMPEROR program, which includes the EMPEROR-Reduced and EMPEROR-Preserved studies. These studies will assess the effect of Empagliflozin on cardiovascular death and hospitalisation for heart failure in adults with chronic heart failure with decreased or preserved ejection fraction, respectively.
The empagliflozin chronic heart failure program consists of the EMPEROR-Reduced and EMPEROR-Preserved studies, the EMPERIAL-Reduced and EMPERIAL-Preserved studies and the EMPA-VISION study. These studies are evaluating the efficacy and safety of empagliflozin in more than 9,000 adults with chronic heart failure, including those with and without diabetes.
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