medwireNews: The US FDA has expanded the indication for empagliflozin to include all adults with heart failure.
The sodium-glucose cotransporter 2 inhibitor was previously approved in for use people with heart failure and reduced ejection fraction, but the positive results of the EMPEROR-Preserved trial have prompted the FDA to extend the indication to include people with preserved ejection fraction. The trial showed a highly significant 21% reduction in the risk for heart failure hospitalization or cardiovascular death for participants given empagliflozin rather than placebo.
The other approved uses of empagliflozin are to reduce glucose levels in adults with type 2 diabetes and to reduce the risk for cardiovascular death in those who also have established cardiovascular disease.
The same expansion of indication was also recommended by the EMA’s Committee for Medicinal Products for Human Use at the end of January.
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