Empagliflozin Gets Breakthrough Tx Status for Heart Failure With Preserved Ejection Fraction

The FDA has granted Breakthrough Therapy designation to empagliflozin for the treatment of adults with heart failure with preserved ejection fraction. This designation was based on the results of a phase 3 trial, EMPEROR-Preserved, which showed that empagliflozin reduced the risk of cardiovascular death or hospitalization for heart failure by 21%. It also slowed kidney function decline and had a consistent safety profile. Empagliflozin is marketed under the name Jardiance and was approved by the FDA in August 2021 for adults with chronic heart failure with or without type 2 diabetes. This approval was based on the results of the EMPEROR-Reduced trial, which showed a 25% reduction in the risk of cardiovascular death or hospitalization for heart failure compared to placebo.

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