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European Drug Regulator Queries AstraZeneca about U.S. Probe into Drug Trial

Filed November 8th, 2013 Laurie

The European Medicines Agency (EMA) requested this week that AstraZeneca provide more information about the U.S. probe into a clinical trial of the company’s new heart drug, Brilinta.

EMA said it had contacted AstraZeneca earlier this week after the drug maker revealed that the U.S. Department of Justice (DOJ) was investigating the company over a drug trial that paved the way for Brilinta’s marketing approval, according to Reuters.

Britain’s second-largest drug maker used an 18,000-patient study to get its Brilinta approved in 2011, but the company was already under scrutiny by some medical experts who questioned the way the study was conducted. Neither AstraZeneca nor the DOJ have revealed the exact nature of the U.S. probe’s focus.

Many experts say it is related to the company’s handling of the study; they also cite a report that patients in the trial monitored by AstraZeneca were reported as benefiting more from Brilinta than those patients monitored by an independent clinical research organization, Reuters reported.

Sales of Brilinta have been disappointing since its launch, though AstraZeneca recently stepped up its marketing efforts in the hopes that further clinical tests will accentuate its value in preventing heart attacks, according to Reuters.

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