medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended extension of the dapagliflozin license to encompass all heart failure irrespective of the ejection fraction.
The sodium-glucose cotransporter 2 inhibitor was previously approved for people with symptomatic heart failure and a reduced ejection fraction, but the recent DELIVER trial demonstrated its efficacy in people with a preserved ejection fraction.
Dapagliflozin is also approved for treatment of type 2 diabetes in adults and children older than 10 years, and for treatment of chronic kidney disease.
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