U.S. to Investigate Clinical Trial Used for AstraZeneca Heart Drug BrilintaNov 4, 2013
Drug maker AstraZeneca is facing an investigation launched by U.S. authorities regarding a clinical trial of its heart drug, Brilinta.
According to a 4-Traders.com report, the U.S. Justice Dept. (DOJ) in late October sent a civil investigation demand to the British drug maker seeking documents and information related to its clinical trial for Brilinta, named Plato.
AstraZeneca says it plans to cooperate with the DOJ, according to the 4-Traders.com report, which quoted the company CEO saying he was "very confident" in the findings of the clinical trial, which was "guided by a strong academic group…"
AstraZeneca did not reveal details regarding specifics of the investigation; a DOJ spokesman said he had no immediate comment.
The results of the 18,000-patient PLATO test, released at a medical meeting in 2009, formed the basis for the drug’s approval in the United States, 4-Traders.com reports, adding that the drug Brilinta was launched in 2011.
Several medical experts have been critical of various aspects of the study, which relied heavily on Poland and Hungary for participants; the two countries together accounted for 21 percent of all subjects, more than double the number from the U.S. and Canada combined, according to the 4-Traders.com report. That, in itself, has been criticized.
Numerous questions about the conduct of the study were also raised in a recent paper published by the International Journal of Cardiology by James DiNicolantonio of Ithaca New York and Ales Tomek of Charles University in Prague. In particular, 4-Traders.com notes, their analysis revealed that patients in the PLATO trial that AstraZeneca monitored were reported as gaining more benefits from Brilinta than those monitored by an independent clinical research organisation.
AstraZeneca is hoping that Brilinta will be used by heart doctors in place of aspirin in the treatment of cardiovascular patients, 4-Traders.com notes.