AstraZeneca has announced the US Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in patients with type 2 diabetes and either established cardiovascular disease (CVD) or at serious risk of CV outcomes.
This follows a similar decision by the European Union in August 2019, when the medicines agency updated its marketing authorisation for Farxiga.
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The FDA’s decision was based upon results from the DECLARE-TIMI 58 trial, which evaluated 58 CV outcomes, making it the largest of its kind for a sodium-glucose cotransporter 2 (SGLT2) inhibitor.
Full results of the Phase III, randomised control trial were published in January in the New England Journal of Medicine.
AstraZeneca subsidiary BioPharmaceuticals’ Business Unit executive vice-president Ruud Dobber 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.
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By GlobalData“Farxiga now offers the opportunity for physicians to act sooner and reduce the risk of hospitalisation for heart failure.
Co-principal investigator of DECLARE-TIMI 58 from Brigham and Women’s Hospital and Harvard Medical School Dr Stephen Wiviott 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.
“This 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.”
Farxiga is a first-in-class, oral once daily SGLT2 inhibitor, which is also being studied in other CV-related outcomes, in patients both with and without type 2 diabetes. An example is the DAPA-HF trial where AstraZeneca is studying the SGLT2 inhibitor in heart failure patients with reduced ejection fraction. AstraZeneca has received fast track designation for this indication from the FDA.
