AstraZeneca on Monday said that that the US Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said: “Farxiga is the first SGLT2 inhibitor approved in the US to reduce the risk of hospitalisation 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 hospitalisation for heart failure.”
Dr. Stephen Wiviott of Brigham and Women’s Hospital and Harvard Medical School, Boston, US 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.”
AstraZeneca said that today’s US FDA approval follows the update to the marketing authorisation in the EU in August 2019. Farxiga is also under regulatory review in China with a decision anticipated in the first half of 2020.