AstraZeneca has received confirmation from the United States Department of Justice that it is closing its investigation into PLATO, a clinical trial with Brilinta (ticagrelor). The government is not planning any further action.
Pascal Soriot, chief executive officer, said: “We welcome the Department of Justice’s decision not to pursue further action. We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefit Brilinta offers to patients around the world suffering from acute coronary syndrome. As one of AstraZeneca’s growth platforms, we are committed to delivering the full potential of this important medicine.”
AstraZeneca recently announced the start of the SOCRATES trial, studying Brilinta for patients with acute ischemic stroke or transient ischemic attack, and the THEMIS study in patients with Type 2 diabetes and coronary atherosclerosis. These studies form part of PARTHENON, AstraZeneca’s largest ever clinical trial programme, involving more than 80,000 patients worldwide. The programme also includes two trials that have recently completed recruitment; EUCLID for patients with Peripheral Artery Disease and PEGASUS, studying Brilinta for secondary prevention in patients with previous myocardial infarction. Headline results for PEGASUS are expected in the first quarter of 2015.
In 2011, the US Food and Drug Administration approved Brilinta for the treatment of patients with acute coronary syndrome (ACS). Brilinta has been approved by regulatory authorities in over 100 countries and is included in 11 major ACS treatment guidelines globally, including six established US treatment guidelines. The trial manuscript from the PLATO executive committee was first published in the New England Journal of Medicine. Following additional rigorous peer-review, over 30 PLATO sub-analyses articles have subsequently been published. The combination of these global reviews makes the PLATO data set one of the most widely analysed clinical trials.