AstraZeneca has secured approval from the US Food and Drug Administration (FDA) for its 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.
The FDA approval was based on data from the DECLARE-TIMI 58 CV outcomes trial (CVOT). It is claimed to be the largest sodium-glucose cotransporter 2 (SGLT2) inhibitor CVOT conducted to date to assess T2D patients with multiple CV risk factors or established CV disease.
Farxiga is a first-in-class and oral once-daily SGLT2 inhibitor developed as both monotherapy, as well as part of combination therapy to enhance glycaemic control.
In August this year, the European Commission has approved an update to the marketing authorisation for Forxiga to include positive cardiovascular (CV) outcomes and renal data based on phase III DECLARE-TIMI 58 trial in adults with T2D.
The company already secured fast track designation from FDA 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 DAPA-HF and DELIVER trials.
It also secured fast track designation for Farxiga 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.
AstraZeneca 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. Farxiga now offers the opportunity for physicians to act sooner and reduce the risk of hospitalisation for heart failure.”