by Christopher Freeburn | October 31, 2013 9:09 am
On Thursday, AstraZeneca (AZN) announced that the U.S. Department of Justice has launched a civil investigation linked to its new heart treatment.
Federal regulators are probing a clinical trial — referred to as the PLATO study — that helped secure U.S. Food and Drug Administration (FDA) approval for Brilinta, a platelet aggregation inhibitor used to reduce the risks of strokes or heart attacks in patients with cardiac problems. The Justice Department has requested that the company turn over all documents and data pertaining to the clinical trial, Reuters noted.
Brilinta received marketing approval in the U.S. from the FDA in 2011. It was approved for sale in Europe in 2010.
Sales for the drug have been sluggish, generating just $75 million during the third quarter, up from $65 million in the prior quarter.
AztraZeneca says it will cooperate fully with regulators.
In June, AstraZeneca announced a partnership with Roche (RHHBY) under which the two companies will provide their research data to MedChemica, which will analyze the data to accelerate drug development.
Shares of AztraZeneca sank more than 1% in Thursday pre-market trading.
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