US Department of Justice Investigating PLATO Ticagrelor Trial

Shelley Wood

October 31, 2013

WILMINGTON, DE — The US Department of Justice (DoJ) is investigating AstraZeneca's PLATO trial of ticagrelor (Brilinta). A company spokesperson confirmed to heartwire that the company received a civil investigative demand from the DoJ's civil division on October 21 "seeking documents and information regarding PLATO. . . . AstraZeneca intends to cooperate with the inquiry."

As long covered by heartwire , the FDA originally took an extended period of time to pick over the pivotal PLATO study before approving the antiplatelet drug. The trial results have been dogged by questions surrounding the apparent geographic discrepancies in the trial and in particular why there was a trend toward worse outcomes with ticagrelor vs clopidogrel at North American sites. Other questions raised have included study site monitoring: sites where the company was not in charge of trial monitoring are also the sites where patients did not do as well on the study drug. The timing of the deaths in the study have also raised eyebrows.

Whatever the reason behind the DoJ's request, AstraZeneca would not provide any details, other than to note that the PLATO trial "was guided by a 10-member academic group that oversaw the medical, scientific, and operational conduct of the study and had independent access to the PLATO data." The trial was also monitored by an independent data safety management board, the spokesperson added, and subsequently "fully reviewed and rigorously analyzed by the FDA, resulting in the approval of Brilinta for the treatment of patients with ACS in 2011."

The drug has received 100 marketing authorizations worldwide.

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