US Government Ends Probe of AstraZeneca’s Brilinta
AstraZeneca reports it 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 company’s drug to treat acute coronary syndrome. The company reports that the government is not planning any further action.
In October 2013, AstraZeneca received a civil investigative demand from the US Department of Justice seeking documents and information related to the PLATO trial. PLATO was a large (18,624 patients in 43 countries), head-to-head patient outcomes study of 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 events in acute coronary syndrome patients, above and beyond that afforded by clopidogrel plus aspirin. Patients were treated for at least six months and up to 12 months. The US Food and Drug Administration approved Brilinta in 2011 to treat acute coronary syndrome.
“AstraZeneca has cooperated with the government enquiry, which focused on questions that have been raised previously in public about the trial,” said AstraZeneca in a statement. “Similar questions have been responded to by the independent PLATO Executive Committee which led the clinical trial.”