FDA Fast Track designation for development of SGLT2i therapy for chronic heart failure

News - July 4, 2019

The US Food and Drug Administration (FDA) has granted Fast Track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalisation for heart failure (HF) in people with chronic HF. Empagliflozin is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in the label in several countries. 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 hospitalisation for HF in adults with chronic HF with reduced or preserved ejection fraction (HFrEF or HFpEF, respectively).

The two EMPEROR Phase III studies include more than 8,500 people with chronic HF (preserved: anticipated number of patients: 5250, reduced: 3600), and are designed to assess the effect of treatment with empagliflozin on cardiovascular death and hospitalisation for chronic HF as primary endpoints. The EMPEROR studies are part of the empagliflozin chronic HF programme. Both studies are estimated to be completed in 2020.

Source: press release Boehringer Ingelheim, June 26, 2019

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