FDA approves AstraZeneca’s Farxiga for type 2 diabetes patients with risk of CVD

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. 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.