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New US approval for AZ’ Brilinta

AstraZeneca’s Brilinta (ticagrelor) has been cleared by US regulators to cut the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD).

The decision was based on data from the Phase III THEMIS trial, which showed a significant 10% 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 II diabetes at high-risk of a first heart attack or stroke.

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

“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,” noted Deepak Bhatt, THEMIS trial co-chair, executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital, and Professor of Medicine at Harvard Medical School.

Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AZ, said Brilinta’s approval in this setting 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.”

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.

The drug is currently 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.