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21 Feb 2016

European marketing approval of AstraZeneca’s Brilique

AstraZeneca, a global, innovation-driven biopharmaceutical business, announced that the European Commission has granted marketing authorisation for Brilique (ticagrelor) at a new 60mg dose for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event. Treatment may be started as continuation therapy after an initial one-year treatment with Brilique 90mg and aspirin or other dual anti platelet therapy.

Brilique is an oral antiplatelet treatment that works by inhibiting platelet activation. Brilique 90mg is already approved in the EU for the prevention of atherothrombotic events in adults with acute coronary syndrome (ACS). In the management of ACS, the recommended maintenance dose of Brilique is 90mg twice daily during the first year after an ACS event.

Now, after the first year, patients with a history of heart attack can continue to be treated with the lower dose Brilique 60mg twice daily, which should be taken with a daily maintenance dose of aspirin of 75-150mg.

The EU approval was based on the results from the PEGASUS TIMI-54 study, a large-scale outcomes trial involving more than 21,000 patients, presented at American College of Cardiology Congress (ACC) in March 2015 and simultaneously published in the New England Journal of Medicine. PEGASUS TIMI-54 investigated ticagrelor tablets plus low-dose aspirin, compared to placebo plus low dose aspirin, for the long-term prevention of cardiovascular (CV) death, heart attack and stroke in patients who had experienced a heart attack one to three years prior to study enrollment. The study showed that Brilique significantly reduced the primary endpoint of CV death, MI or stroke compared to placebo. The rates at 3 years were 7.77 per cent in the ticagrelor 60mg arm and 9.04 per cent in the placebo arm.

This approval is applicable to all 28 European Union member countries plus Iceland, Norway and Liechtenstein.

Today’s announcement follows the approval on September 3, 2015 of Brilinta (ticagrelor) 60mg by the US Food and Drug Administration, to be used in patients with a history of heart attack beyond the first year.

Brilique is an oral antiplatelet treatment for acute coronary syndrome (ACS). Brilique is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Brilique works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic CV events, such as a heart attack or CV death, in patients with ACS.

PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome – Thrombolysis In Myocardial Infarction Study Group) is one of AstraZeneca’s largest ever outcomes trials with more than 21,000 patients from over 1,100 sites in 31 countries in Europe, the Americas, Africa and Australia/Asia. It is being conducted in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group from Brigham and Women’s Hospital (Boston, MA, USA).

The PEGASUS-TIMI 54 study investigated the efficacy and safety of both Brilique 60mg and 90mg, twice daily, compared to placebo on a background of low dose aspirin, for the long-term prevention of atherothrombotic events in patients who suffered a heart attack one to three years prior to enrolment. The primary efficacy endpoint is time to first occurrence of any event from the composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction or non-fatal stroke.

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