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June 1, 2020

FDA Approves AstraZeneca’s Brilinta to Reduce the Risk of a First Heart Attack or Stroke in High-Risk Patients With CAD

June 1, 2020—AstraZeneca announced FDA approval for Brilinta (ticagrelor) to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD). The approval was based on positive results from the phase 3 THEMIS trial.

According to the company, this is the first regulatory approval for aspirin plus Brilinta dual antiplatelet therapy in patients who have a high cardiovascular (CV) risk but without a history of heart attack or stroke, stated AstraZeneca.

AstraZeneca stated that the THEMIS trial showed a statistically significant reduction in the primary composite endpoint of major adverse CV events at 36 months with aspirin plus Brilinta 60 mg versus aspirin alone in patients with CAD and type 2 diabetes (T2D) at high risk of a first heart attack or stroke. The primary composite endpoint was driven by a reduction in heart attack and stroke.

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 with aspirin alone in patients who had CAD and T2D without a history of heart attack or stroke. Although this indication is not limited to this setting, the efficacy of Brilinta was established in a population with T2D in the THEMIS trial. The safety profile for Brilinta was consistent with the known profile of the medicine, with an increased risk of bleeding events observed.

Deepak L. Bhatt, MD, and Gabriel Steg, MD, are cochairs of the THEMIS trial

In October 2019, the data from the THEMIS trial were published by Dr. Steg, et al in The New England Journal of Medicine (2019;381:1309-1320). In September, Dr. Bhatt et al published data from the THEMIS-PCI subanalysis in The Lancet (2019;394:1169-1180).

“CAD is a potentially life-threatening condition that causes significant morbidity in many people,” commented Dr. Bhatt in the company press release. “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.” Dr. Bhatt is Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School in Boston, Massachusetts.

Dr. Steg, who is Professor at Université de Paris in Paris, France, stated, “THEMIS for ticagrelor was a large, multinational trial of more than 19,000 patients with CAD and T2D. Around one-third of patients with CAD have T2D, 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.”

In January 2020, AstraZeneca announced high-level results from the phase 3 THALES trial that showed aspirin plus Brilinta 90 mg reduced the risk of the composite of stroke and death at 30 days after an acute ischemic stroke or transient ischemic attack, compared with aspirin alone.

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

Brilinta is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome. Additionally, it is approved in more than 70 countries for the secondary prevention of CV events among high-risk patients who have experienced a previous myocardial infarction. Brilinta is not indicated in patients with minor acute ischemic stroke or high-risk transient ischemic attack, advised AstraZeneca.

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