AstraZeneca Forxiga recommended for nod in EU for chronic heart failure
Heart failue is a life-threatening chronic disease in which the heart cannot pump enough blood around the body, affecting 15 million people in the EU.;
UK: AstraZeneca has recently announced that the company'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).
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 The New England Journal of Medicine and results from a pre-specified, patient-level, pooled analysis of the DAPA-HF and DELIVER Phase III trials published in Nature Medicine. The pooled analysis showed Forxiga to be the first HF medication to demonstrate mortality benefit across the full ejection fraction range.
HF is a life-threatening chronic disease in which the heart cannot pump enough blood around the body, affecting 15 million people in the EU. 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 management.
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. 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. 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."
Read also: AstraZeneca India names Dr Sanjeev Panchal as Country President, MD
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.