The EC nod for the sodium-glucose cotransporter 2 (SGLT2) inhibitor (known as Farxiga in the United States) follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency in December 2022.
The committee's decision was based on results from the DELIVER phase 3 trial, which showed clear clinical benefits of the SGLT2 inhibitor in patients with HF regardless of their left ventricular function.
The study was published last August in the New England Journal of Medicine and presented at the European Society of Cardiology's annual congress (ESC Congress 2023), with coverage by theheart.org | Medscape Cardiology.
The data support the use of SGLT2 inhibitors as "foundational agents for virtually all patients with heart failure" regardless of their ejection fraction or whether or not they have type 2 diabetes, said study presenter Scott D. Solomon, MD, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts.
The US Food and Drug Administration is currently reviewing AstraZeneca's application to expand the HF indication for dapagliflozin in the United States.