Development of Brilinta Reversal Agent Initiated by AstraZeneca
AstraZeneca announced that it has initiated a pre-clinical development program to evaluate the ability of investigational antibody, MEDI2452 to rapidly and specifically reverse the antiplatelet effects of Brilinta (ticagrelor) in rare emergencies, such as urgent surgery or major bleeding. MEDI2452 is a neutralizing antibody that binds to ticagrelor and AR-C124910XX, the ticagrelor active metabolite.
Development of MEDI2452 is being conducted along with the PARTHENON clinical program for ticagrelor, which included five registration studies involving around 80,000 patients across the broad spectrum of atherothrombotic disease. The PEGASUS-TIMI 54 study, involving more than 21,000 patients, will be the next study within the program to complete, with top line results expected in the first quarter of 2015. PEGASUS-TIMI 54 is designed to assess the efficacy and safety of ticagrelor on a background of low-dose aspirin, for the long-term prevention of atherothrombotic events in patients, aged ≥50, who suffered a heart attack 1–3 years prior to study enrollment, and who have one additional cardiovascular risk factor.
Recently the American Heart Association and the American College of Cardiology guidelines for the management of patients with non-ST-elevation acute coronary syndromes (NSTE-ACS) were updated. The guidelines support differentiation among currently available P2Y12 inhibitors. In a Class IIa recommendation, Brilinta is now preferred over clopidogrel for the management of NSTE-ACS patients who undergo an early invasive angiography with intent for percutaneous coronary intervention, if appropriate, ischemia-guided (eg, medically managed) strategy, or those who receive a coronary stent. The guidelines also include Brilinta as a Class I as a treatment option in the management of NSTE-ACS patients.
Brilinta is indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) (unstable angina, non–ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]).
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