BRILINTA Approved in the US to Reduce the Risk of a First Heart Attack or Stroke in High-Risk Patients with Coronary Artery Disease

發(fā)布時間： 2020-06-05 閱讀：999次

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June 01, 2020 - AstraZeneca’s 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.

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 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.