AstraZeneca’s diabetes drug Farxiga (dapagliflozin) has succeeded in a phase 3 cardiovascular (CV) outcomes trial (CVOT) by delivering a statistically-significant reduction in hospitalization for heart failure or CV death in patients with type-2 diabetes (T2D).
Farxiga was assessed in a trial, dubbed DECLARE-TIMI 58, in more than 17,000 T2D adult patients having multiple CV risk factors or established CV condition.
In the five-year trial held across 33 countries, Farxiga achieved its primary safety endpoint of non-inferiority for major adverse cardiovascular events (MACE).
Apart from that, fewer MACE events were recorded with the AstraZeneca drug for the other primary efficacy endpoint. However, it could not achieve statistical significance in comparison to placebo.
DECLARE-TIMI 58 trial co-principal investigator Stephen Wiviott said: “The DECLARE-TIMI 58 results offer compelling evidence that dapagliflozin helps to address an important medical need among a diverse group of patients with type-2 diabetes by reducing the composite of hospitalisation for heart failure or CV death, with a safety profile supportive of broad use.”
AstraZeneca revealed that the findings from the DECLARE-TIMI 58 trial confirmed the well-established safety profile of Farxiga.
AstraZeneca global medicines development vice president, cardiovascular, renal and metabolism head Elisabeth Björk said: “Farxiga has achieved a statistically-significant and clinically-important reduction in hospitalisation for heart failure or CV death in a broad range of patients with type-2 diabetes and cardiovascular risk.
“The results from this landmark trial are especially important since heart failure is an early and frequent complication of diabetes and associated with hospitalisations that result in a considerable societal and economic burden.”
Farxiga is an oral, daily once selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2). It has been indicated as monotherapy and also in combination therapy as an adjunct to diet and exercise in adults with T2D to boost glycaemic control.
Farxiga is not indicated to reduce the risk of CV events, CV death or hHF. It has a clinical trial program of over 35 completed and ongoing phase IIb/III trials in over 35,000 patients, as well as more than 1.8 million patient-years’ experience.
Earlier this month, AstraZeneca secured an approval from the US Food and Drug Administration (FDA) for its CD22-directed cytotoxin Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukaemia.