The new indication expands Brilinta treatment to high-risk coronary patients without a history of stroke or heart attack
AstraZeneca gets FDA approval for Brilinta to reduce the risk of stroke. (Credit: AstraZeneca.)
AstraZeneca has secured the US Food and Drug Administration (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).
Brilinta is an oral, reversible, direct-acting P2Y12 receptor antagonist that inhibits platelet activation, and, in combination with aspirin, would reduce the risk of MACE defined as myocardial infarction (M), stroke or CV death, in patients with ACS or a history of MI.
The drug has been 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 patients who experienced prior myocardial infarction.
AstraZeneca biopharmaceuticals business unit executive vice president Ruud Dobber 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 FDA approval for Brilinta was based on positive results from the Phase 3 THEMIS trial
The US regulatory approval was based on positive results from the Phase 3 THEMIS trial, which demonstrated positive results for aspirin plus Brilinta, compared to aspirin alone in patients with CAD and type-2 diabetes (T2D) at high-risk of a first heart attack or stroke.
The study has showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular (CV) events, including heart attack and stroke, at 36 months.
In the THEMIS trial, Brilinta has established efficacy in a population with T2D, and showed a consistent safety profile with the known profile of the medicine with an increased risk of bleeding events observed.
THEMIS trial co-chair Deepak L Bhatt 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.”
THEMIS trial co-chair Gabriel Steg 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.”