AstraZeneca's Brilinta Approved in the U.S. to Reduce Risk of First Heart Attack or Stroke in High-Risk CAD Patients

Reposted from: Immediate Pharma News

On June 1, 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 artery disease (CAD), the most common type of heart disease. This marks the first regulatory approval of aspirin combined with ticagrelor for dual antiplatelet therapy in patients at high cardiovascular (CV) risk but without a history of heart attack or stroke. The drug was first approved by the FDA on July 20, 2011, for the treatment of acute coronary syndrome (ACS). On November 22, 2012, it received approval from China’s National Medical Products Administration for use in patients with acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction), including those receiving medical therapy and percutaneous coronary intervention (PCI), to reduce the incidence of thrombotic cardiovascular events.

The U.S. FDA approval was based on the positive results of the Phase 3 THEMIS clinical trial. The trial demonstrated that, in patients with coronary artery disease (CAD) and type 2 diabetes (T2D) at high risk for a first heart attack or stroke, treatment with aspirin plus ticagrelor for 36 months resulted in a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular (CV) events compared to aspirin alone. The primary composite endpoint consisted of a reduction in heart attacks and strokes.

THEMIS was a multinational, randomized, double-blind, phase 3 clinical trial designed to test the hypothesis that the combination of ticagrelor and aspirin reduces the risk of major adverse cardiovascular events (MACE). Initiated in early 2014, the THEMIS trial is one of the largest randomized trials conducted to date in patients with type 2 diabetes. Coronary artery disease (CAD) was defined as prior percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), or at least 50% stenosis in a coronary artery. Furthermore, THEMIS-PCI was a clinically relevant, prespecified subgroup analysis of patients with a history of PCI (11,154 patients, accounting for 58% of the total study population). The THEMIS trial demonstrated that among patients with CAD and type 2 diabetes without a history of myocardial infarction or stroke, long-term treatment with ticagrelor plus aspirin, compared with aspirin monotherapy, reduced the relative risk of the composite endpoint of myocardial infarction, stroke, and cardiovascular death by 10% (absolute risk reduction: 0.8%; 7.7% vs. 8.5%). Although this indication is not limited to this specific population, the efficacy of ticagrelor was established in the type 2 diabetes cohort of the THEMIS trial.

Brilinta (ticagrelor) is an oral, reversible, direct-acting P2Y12 receptor antagonist that exerts its effect by inhibiting platelet activation. In patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI), Brilinta in combination with aspirin has been shown to significantly reduce the risk of major adverse cardiovascular events (MACE), defined as myocardial infarction (MI, heart attack), stroke, or cardiovascular death. The combination of ticagrelor and aspirin is indicated for the prevention of atherothrombotic events in adult patients with ACS, or in patients with a history of MI who are at high risk for atherothrombotic events. Regulatory applications to extend this approved indication for ticagrelor, based on the THEMIS trial, are also under regulatory review in the European Union, Japan, and China.

References:

[1] Brilinta approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease. Retrieved 2020-06-01, from https://www.astrazeneca.com/media-centre/press-releases/2020/brilinta-approved-in-the-us-to-reduce-the-risk-of-a-first-heart-attack-or-stroke-in-high-risk-patients-with-coronary-artery-disease.html

Original Title: AstraZeneca’s Ticagrelor Approved by FDA to Reduce Risk of First Heart Attack or Stroke in Patients with Coronary Artery Disease

▽Follow [WuXi AppTecDe】WeChat Official Account