Anglo-Swedish drug major AstraZeneca has reported top-line results from the Phase III PLATO trial, which demonstrate that Brilinta (ticagrelor) achieved a statistically significant primary efficacy endpoint versus Sanofi-Aventis' Plavix (clopidogrel), in the prevention of cardiovascular events in patients with acute coronary syndromes. The news sent AstraZeneca's shares up 5% on May 11, while Sanofi fell 1.3%
The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke and CV death. In PLATO, the overall safety profile for the investigational oral antiplatelet drug was in line with the safety data observed in mid-stage studies, the firm noted. Given the size of the PLATO trial, further analysis of the entire database, secondary variables and subgroups is ongoing, and AstraZeneca plans to present the data at the European Society of Cardiology annual meeting in August. The submission of the agent to regulatory authorities remains on schedule for the fourth quarter.
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