U.S. FDA grants fast track designation to empagliflozin for the treatment of chronic heart failure

Eli Lilly

26 June 2019 - FDA's Fast Track designation for empagliflozin underscores the urgent need for new potential treatment options for the 6.5 million people in the U.S. who have heart failure.

The U.S. FDA has granted fast track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure, Boehringer Ingelheim and Eli Lilly and Company announced. The Fast Track designation facilitates the development of new therapies that fill an unmet medical need for serious conditions in an effort to expedite the availability of new treatment options.

This designation is for the ongoing EMPEROR program, which consists of the EMPEROR-Reduced and EMPEROR-Preserved studies. These studies will evaluate the effect of empagliflozin on cardiovascular death and hospitalization for heart failure in adults with chronic heart failure with reduced or preserved ejection fraction, respectively.

Read Eli Lilly press release


Michael Wonder

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Michael Wonder

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Medicine , US , Fast track