AZ plans heart attack study for Brilique
pharmafile | October 8, 2010 | News story | Research and Development, Sales and Marketing | AstraZeneca, Brilinta, Brilique
AstraZeneca is due to begin enrolling patients into a new study of its oral antiplatelet Brilique (ticagrelor) before the end of this year.
Its purpose is to look at the drug’s efficacy in people who have suffered a heart attack over the past one to three years.
At the moment acute coronary syndrome (ACS) patients receive dual antiplatelet therapy for up to 12 months, followed by longer-term treatment with aspirin on its own.
“This study represents a further investment in our understanding of ticagrelor and the impact on post-ACS patients over the long term,” said Dr Jonathan Fox, vce president of clinical development at AstraZeneca.
The study, PEGASUS-TIMI 54, will be carried out with the Boston-based Brigham and Women’s Hospital, a teaching affiliate of Harvard Medical School.
“After a heart attack, patients remain at significant risk of another heart attack or major adverse cardiovascular event,” explained principal investigator Dr Marc Sabatine.
“PEGASUS-TIMI 54 will study treatment beyond 12 months after a heart attack, with dual antiplatelet therapy of ticagrelor and aspirin.”
Therefore the study aims to see if Brilique and aspirin together will further reduce the risk of subsequent cardiovascular events.
The primary endpoint will be time to first occurrence of any cardiovascular (CV) event including CV death, non-fatal myocardial infarction or non-fatal stroke.
Last month the drug received a positive opinion from the CHMP in Europe, although the FDA is delaying its own review for three months.
Analysts say the drug – whose US brand name is Brilinta – could make $2 billion per annum but it will be up against Sanofi-Aventis’ and Bristol-Myers Squibb’s blockbuster Plavix (clopidogrel).
AstraZenca’s new randomised, double-blind international study aims to recruit 21,000 patients in over 30 countries, with a minimum treatment period of a year.
Patients will be randomised to either Brilique 60 or 90 mg twice daily, or placebo, and will also take once-daily aspirin therapy (75 to 150 mg).
Adam Hill
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