US DoJ closes investigation into AstraZeneca’s PLATO trial for Brilinta

Anglo-Swedish drug major AstraZeneca (LSE: AZN) has received confirmation from the US Department of Justice that it is closing its investigation into PLATO, a clinical trial with cardiovascular drug Brilinta (ticagrelor). The government is not planning any further action.

Last year, AstraZeneca said it was cooperating with a civil investigative demand from the US DoJ, Civil Division seeking documents and information regarding PLATO. PLATO was a large head-to-head patient outcomes study of Brilinta versus clopidogrel, both given in combination with aspirin and other standard therapy. The trial was designed to establish whether Brilinta plus aspirin could achieve a clinically meaningful reduction in cardiovascular (CV) events in acute coronary syndrome (ACS) patients, above and beyond that afforded by clopidogrel plus aspirin. Patients were treated for at least 6 months and up to 12 months.

Chief executive Pascal Soriot 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.”