FDA Gives Green Light To AstraZeneca Ticagrelor

- Jun 16, 2020-

AstraZeneca announced that Brilinta (ticagrelor) has been approved in the United States to reduce the risk of first heart attack or stroke in patients with high-risk coronary heart disease (CAD). CAD is the most common type of heart disease. This is the first time that regulatory agencies have approved aspirin combined with ticagrelor, dual antiplatelet therapy for patients with high risk of cardiovascular (CV) but no history of heart attack or stroke. The drug was first approved by the FDA on July 20, 2011 for patients with acute coronary syndrome (ACS) to reduce the incidence of thrombotic cardiovascular events, and was approved by the China Food and Drug Administration on November 22, 2012 for In patients with acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction), the incidence of thrombotic cardiovascular events is reduced.


The US FDA approval is based on the positive results of the Phase 3 clinical trial THEMIS. The trial showed that in patients with coronary heart disease and type 2 diabetes mellitus (T2D) at high risk of first heart attack or stroke, aspirin combined with ticagrelor was mainly associated with poor cardiovascular at 36 months compared with aspirin alone The main composite endpoint of the event has a statistically significant decrease. The main composite endpoint was a reduction in heart attacks and strokes.


THEMIS is a multi-country, randomized, double-blind phase 3 clinical trial designed to test the hypothesis that the combination of ticagrelor and aspirin can reduce the risk of major adverse cardiovascular events (MACE). The THEMIS trial was launched in early 2014 and is one of the largest randomized trials conducted in patients with type 2 diabetes to date. CAD is defined as percutaneous coronary intervention (PCI), bypass surgery, or coronary artery stenosis of at least 50%. The THEMIS trial showed that in CAD and T2D patients without a history of heart attack or stroke, aspirin combined with long-term ticagrelor therapy reduced the relative risk of composite endpoints of heart attack, stroke, and CV death compared with aspirin monotherapy.10 % (Absolute risk reduction; 0.8%, 7.7% vs 8.5%).