Dapagliflozin gains positive CHMP opinion for CKD indication
medwireNews: The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indication for dapagliflozin to cover chronic kidney disease (CKD).
This follows the FDA approval, based on the positive outcomes of the DAPA-CKD trial, in which all participants had CKD, but only around two-thirds had diabetes.
In the EU, dapagliflozin is already approved for glucose-lowering in people with type 2 diabetes, as an adjunct to insulin for glucose-lowering treatment in people with type 1 diabetes and a BMI of at least 27 kg/m2, and for chronic heart failure with reduced ejection fraction.
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