AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved FARXIGA (dapagliflozin) to reduce the risk of hospitalization for heart failure (hHF) in adults with type 2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
The approval is based on results from the landmark DECLARE-TIMI 58 CV outcomes trial (CVOT), the largest sodium-glucose cotransporter 2 (SGLT2) inhibitor CVOT conducted to date to evaluate T2D patients with multiple CV risk factors or established CV disease.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said: “FARXIGA is the first SGLT2 inhibitor approved in the US to reduce the risk of hospitalization for heart failure in type 2 diabetes patients with established cardiovascular disease or multiple cardiovascular risk factors. This is promising news for the 30 million people living with type 2 diabetes in the US, as heart failure is one of the earliest cardiovascular complications for them, before heart attack or stroke. FARXIGA now offers the opportunity for physicians to act sooner and reduce the risk of hospitalization for heart failure.”
Dr. Stephen Wiviott of Brigham and Women’s Hospital and Harvard Medical School, Boston, and a Senior Investigator with the TIMI study group and co-principal investigator of the trial, said: “DECLARE-TIMI 58 is a landmark trial, offering compelling evidence that dapagliflozin can reduce the risk of heart failure in patients living with type 2 diabetes with multiple risk factors for or established cardiovascular disease. These data could help change the way we approach diabetes management – going beyond a singular focus on glucose control to help address the risk of heart failure in a diverse population of patients.”
Today’s FDA approval follows the update to the marketing authorization in the EU in August 2019. FARXIGA is also under regulatory review in China with a decision anticipated in the first half of 2020.
The FDA has granted Fast Track designation for FARXIGA to reduce the risk of CV death, or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) based on the Phase III trials, DAPA-HF and DELIVER, and Fast Track designation to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease (CKD) based on the Phase III DAPA-CKD trial. FARXIGA is not indicated to reduce the risk of heart failure, CV death or kidney disease.