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AstraZeneca: Farxiga Met Primary Goal In Phase III Cardiovascular Outcomes Trial

AstraZeneca Plc (AZN.L,AZN) announced Monday positive results from the Phase III DECLARE-TIMI 58 cardiovascular outcomes trial or CVOT for Farxiga (dapagliflozin), the broadest SGLT2 inhibitor CVOT conducted to date. The company noted that Farxiga met the primary composite endpoint of a statistically-significant reduction in hospitalisation for heart failure or CV death in a broad patient population.

Farxiga is a first-in-class, oral, once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2) indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise in adults with T2D.

The trial evaluated the CV outcomes of Farxiga vs. placebo over a period of up to five years, across 33 countries and in more than 17,000 adults with type-2 diabetes or T2D who have multiple CV risk factors or established CV disease.

In the DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 trial, Farxiga met its primary safety endpoint of non-inferiority for major adverse cardiovascular events or MACE. Farxiga achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure or CV death, one of the two primary efficacy endpoints. Additionally, fewer MACE events were observed with Farxiga for the other primary efficacy endpoint, however, this did not reach statistical significance.

Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development 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."

Detailed trial results will be presented on November 10 at the American Heart Association Scientific Sessions 2018 in Chicago, USA.

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