Approval of SGLT2i in the EU for treatment of HF patients across full spectrum of LVEF
Dapagliflozin has been approved in the EU beyond the indication of HFrEF to treatment for HF patients across the full spectrum of LVEF, including HFmrEF and HFpEF.
This decision by the EC follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on the results of the DELIVER phase III trial. In a prespecified pooled analysis of DELIVER and DAPA-HF phase III trials, it was shown that dapagliflozin resulted in mortality benefit across the full range of LVEF.
The application for extension of HF indication for dapagliflozin is currently under review in the US and other countries.
Dapagliflozin is approved in adults and children aged 10 years and above for the treatment of insufficiently controlled T2DM as an adjunct to diet and exercise. It is also approved for the treatment of HFrEF in adults and the treatment of CKD in adults based on the findings of the DAPA-HF and DAPA-CKD Phase III trials.
Share this page with your colleagues and friends: