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Forxiga CHMP opinion for symptomatic chronic HF
Forxiga CHMP opinion for symptomatic chronic HF.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 19 December 2022 7:00 GMT\n \n \n \n \n \n \n Forxiga\n \n \n recommended for approval in the EU by CHMP\nfor symptomatic chronic heart failure\n \n \n \n \n \n \n \n \n \n If approved, Forxiga will be the first heart failure therapy indicated across the full ejection fraction range with proven mortality reduction\n \n \n \n \n \n \n AstraZeneca's Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) to extend the indication for heart failure with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF) including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).\n \n \n \n \n \n The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DELIVER Phase III trial, published in\n \n The New England Journal of Medicine\n \n \n 1\n \n \n \n and results from a pre-specified, patient level, pooled analysis of the DAPA-HF and DELIVER Phase III trials published in\n \n Nature Medicine\n \n \n 2\n \n \n \n . The pooled analysis showed Forxigato be the first HF medication to demonstrate mortality benefit across the full ejection fraction range3.\n \n \n \n \n \n HF is a life-threatening chronic disease in which the heart cannot pump enough blood around the body4, affecting 15 million people in the EU5\n . Patients with HFmrEF or HFpEF experience an especially high burden of symptoms and physical limitations, and a poor quality of life, which is why improving health status is a key goal of management6.\n \n \n \n \n \n Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: \"Forxiga has already transformed the standard of care for millions of people in the EU living with heart failure.\n If approved for this new, broader indication for heart failure with mildly reduced or preserved ejection fraction, more patients will be able to benefit from this well-tolerated and guideline-directed treatment\n . As a leader in cardiorenal disease, AstraZeneca is committed to expanding heart failure treatment options, changing the way we treat this complex disease to improve patient outcomes.\"\n \n \n \n \n \n The CHMP recommendation states Forxiga is indicated in adults for the ...