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AstraZeneca Brilinta approved in the US by FDA

AstraZeneca PLC (LON:AZN) Brilinta (ticagrelor) has been approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD), the most common type of heart disease.

The approval by the US Food and Drug Administration (FDA) was based on positive results from the Phase III THEMIS trial. The trial showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular (CV) events at 36 months with aspirin plus Brilinta 60mg versus aspirin alone in patients with CAD and type-2 diabetes (T2D) at high-risk of a first heart attack or stroke.1 The primary composite endpoint was driven by a reduction in heart attack and stroke.

This is the first regulatory approval for aspirin plus Brilinta dual antiplatelet therapy in patients who have a high CV risk, but without a history of heart attack or stroke.

Deepak L. Bhatt, MD, MPH, THEMIS trial Co-Chair, Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, and Professor of Medicine at Harvard Medical School, Boston, US said: “Coronary artery disease is a potentially life-threatening condition that causes significant morbidity in many people. The addition of ticagrelor to aspirin offers a new therapeutic option to decrease the likelihood of both heart attack and stroke, a significant advance in our ability to treat these high-risk patients.”

Gabriel Steg, MD, THEMIS trial Co-Chair and Professor at Université de Paris, said: “THEMIS for ticagrelor was a large, multi-national trial of more than 19,000 patients with coronary artery disease and type-2 diabetes. Around one third of patients with coronary artery disease have type-2 diabetes, putting them at higher risk of heart attack or stroke, than patients without diabetes. Today’s approval brings new hope to patients at risk of experiencing a first heart attack or stroke.”

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said: “Today’s approval of Brilinta is important news for patients with coronary artery disease who will now have a new therapy option to reduce the risk of a first heart attack or stroke. This new indication is a further testament to the overwhelming science supporting Brilinta in the management of patients with coronary artery disease at high risk for cardiovascular events.”

The THEMIS trial demonstrated the relative risk reduction of the composite endpoint of heart attack, stroke and CV death by 10% (absolute risk reduction; 0.8%, 7.7% vs 8.5%) with aspirin plus long-term Brilinta compared to aspirin alone in patients who had CAD and T2D without a history of heart attack or stroke.1 While this indication is not limited to this setting, the efficacy of Brilinta was established in a population with T2D in the THEMIS trial.2 The safety profile for Brilinta was consistent with the known profile of the medicine with an increased risk of bleeding events observed.1

The data from the THEMIS trial and the THEMIS-PCI sub-analysis were published in The New England Journal of Medicine and The Lancet respectively.

Regulatory submissions to expand the approved indication for Brilinta based on the THEMIS trial are also under regulatory review in the EU, Japan and China.

AstraZeneca also recently announced the high-level results from the Phase III THALES trial that showed aspirin plus Brilinta 90mg reduced the risk of the composite of stroke and death at 30 days after an acute ischaemic stroke or transient ischaemic attack, compared to aspirin alone.

Brilinta is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS), and in more than 70 countries for the secondary prevention of CV events among high-risk patients who have experienced a prior myocardial infarction.

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