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