On 28-Mar-2020, AstraZeneca announced that “new data from a sub-analysis of the landmark Phase III DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) trial showed that AstraZeneca’s Farxiga (dapagliflozin) reduced the incidence of the primary composite endpoint of heart failure (HF) worsening or cardiovascular (CV) death compared to placebo, in patients with heart failure with reduced ejection fraction (HFrEF), irrespective of their background therapy (i.e. other medications for heart failure).
Farxiga was evaluated in patients who were receiving a broad range of pharmacological treatments, device therapies and cardiac resynchronisation therapy for HFrEF. A consistent reduction in the primary outcome was observed across all these treatment subgroups.
The results were made available at the American College of Cardiology’s 69th Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC) and were published in the European Heart Journal.
Farxiga is indicated as a monotherapy and as part of combination therapies to improve glycaemic control in adults with type-2 diabetes (T2D). In the US it is also approved to reduce the risk of hospitalisation for HF in patients with T2D and established CV disease or multiple CV risk factors.
In January 2020, the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga to reduce the risk of CV death or the worsening of HF in adults with HFrEF with and without T2D. The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.”
Farxiga Phase III DAPA-CKD trial will be stopped early after overwhelming efficacy in patients with chronic kidney disease