AstraZeneca has received approval from the US Food and Drug Administration (FDA) for Brilinta (ticagrelor) to decrease the risk of a first heart attack or stroke in high-risk patients suffering from coronary artery disease (CAD).
The indication is for the use of Brilinta plus aspirin dual antiplatelet therapy.
Brilinta is an oral, reversible, P2Y12 receptor antagonist that inhibits platelet activation. The drug holds approval in more than 110 countries to prevent atherothrombotic events in adults with acute coronary syndrome (ACS).
It is also approved in more than 70 countries for the secondary prevention of cardiovascular (CV) events in high-risk patients who have had a myocardial infarction previously.
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 approval comes data of the Phase III THEMIS clinical trial, which demonstrated a statistically significant decrease in the primary composite endpoint of major adverse CV events at 36 months with aspirin plus Brilinta 60mg.
THEMIS compared the combination to aspirin alone in patients having CAD and type-2 diabetes (T2D) with high-risk of a first heart attack or stroke. The primary composite endpoint was a decrease in heart attack and stroke.
Data showed a 10% relative risk reduction of the composite endpoint of heart attack, stroke and CV death with the combination treatment versus aspirin alone.
The safety profile for AstraZeneca’s drug was observed to be consistent with its known profile but with an increased risk of bleeding events.
Last month, AstraZeneca and its partner Daiichi Sankyo secured breakthrough therapy designation (BTD) from the FDA for Enhertu to treat non-small cell lung cancer (NSCLC).