The FDA approved AstraZeneca's Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure in adults with type 2 diabetes and established cardiovascular (CV) disease or multiple CV risk factors, the company reported Monday. Ruud Dobber, executive vice president of AstraZeneca's biopharmaceuticals unit, noted that the drug "is the first SGLT2 inhibitor approved in the US" in this indication.
The expanded approval is supported by results from the Phase III DECLARE-TIMI 58 CV outcomes study. The trial involved more than 17,160 adults with type 2 diabetes at risk of CV events, including patients with multiple CV risk factors or established CV disease, and also assessed key renal secondary endpoints.
AstraZeneca reported last year that in the trial, Farxiga significantly reduced the risk of the primary composite endpoint of hospitalisation for heart failure or CV death by 17% versus placebo. The finding was driven by a significant 27% lowering in the risk of hospitalisation for heart failure. The company recently unveiled data from a new analysis showing that Farxiga also cut the rate of kidney disease progression or renal death by 47%.
In August, the European Commission approved a label update for the drug, which is marketed in the region as Forxiga, to include positive CV outcomes and renal data from DECLARE-TIMI 58. Meanwhile, AstraZeneca said Farxiga is also under regulatory review in China in this indication, with a decision anticipated in the first half of 2020.
Farxiga was fast-tracked by the FDA last month to reduce the risk of CV death, or the worsening of heart failure in adults with heart failure with reduced ejection fraction or with preserved ejection fraction based on the Phase III DAPA-HF and DELIVER trials, respectively. The drug has also received a fast-track designation to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease based on the late-stage DAPA-CKD trial.
Farxiga is currently indicated as monotherapy and as part of a combination therapy to improve glycaemic control in adults with type 2 diabetes. However, the FDA recently rejected AstraZeneca's filing to expand Farxiga's label to include use in certain adults with type 1 diabetes. The drug has been approved for this indication in Europe and Japan.
For related analysis, see ViewPoints: Not just diabetes- AstraZeneca positions Farxiga for broader uptake.
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