News Inferno; November 4, 2013
British drug maker AstraZeneca in under investigation by the U.S. Department of Justice over a major clinical trial involved in the approval of its heart drug Brilinta (ticagrelor).
AstraZeneca said on Thursday that it had received a civil investigative demand from the Department of Justice (DOJ) for documents and information about the so-called PLATO study (PLATelet Inhibition and Clinical Outcomes). AstraZeneca chief executive Pascal Soriot said the company would cooperate with the investigation. Soirot said he was “very confident” in the findings of the clinical trial, because “a strong academic group” had overseen the trial, 4-Traders.com reports.
The company did not disclose the nature of the investigation, and DOJ spokesman Peter Carr had no immediate comment on the case, according to 4-Traders. The PLATO study, which included 18,000 patients was first reported at a medical meeting in 2009 and then formed the basis of drug approval applications in the United States and other countries. Brilinta, a blood thinner, received Food and Drug Administration (FDA) approval in July 2011.