Anglo-Swedish drugmaker AstraZeneca has unveiled plans for a 21,000-patient outcomes study of its bloodthinner Brilinta/Brilique in an attempt to cement the drug’s long-term safety and efficacy profile.
Enrolment in the PEGASUS-TIMI 54 study will begin sometime during the fourth quarter, the firm said, and will involve patients who have had a heart attack between one and three years prior to taking part to determine whether a combination of Brilinta (ticagrelor) and aspirin will cut the risk of further cardiovascular events compared to aspirin alone.
Patients will be randomised for treatment with Brilinta 60mg or 90mg twice daily or a placebo, in addition to once-daily aspirin therapy (75mg to 150mg), for at least 12 months, and the primary efficacy endpoint is the time to first (if any) cardiovascular event, including death, non-fatal myocardial infarction or non-fatal stroke.
AstraZeneca has high hopes for its antiplatelet therapy, which analysts are forecasting will generate peak sales of around $2 billion, according to Reuters, and so far things are looking pretty good.
Approval in Europe is expected imminently after last week advisors to the European Medicines Agency backed the drug, which will be sold there as Brilique, for the treatment of acute coronary syndromes, while across the pond US regulators are currently carrying out a review which should be complete by mid-December.