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European Union Drug Regulator Questions AstraZeneca Over Heart Drug Trial

Nov 8, 2013

The European Medicines Agency (EMA), a major drug regulator, has asked drug maker AstraZeneca to provide more information about a U.S. probe into a clinical trial of the company's heart drug Brilinta.

"The EMA takes seriously any information that may have an impact on the profile of a drug's benefits and risks," spokeswoman Monika Benstetter told Reuters. The U.S. Department of Justice (DOJ) launched an investigation into the clinical trial of Brilinta (ticagrelor) that raises concerns about the product's future.

The 18,000-patient study formed the basis of AstraZeneca’s application to the U.S. Food and Drug Administration (FDA for marketing approval for Brilinta, which was granted in 2011. Even before the DOJ announcement, some medical experts had questioned the way the trial was conducted, Reuters reports. But AstraZeneca CEO Pascal Soriot said last week he was “very confident” in the findings of the pivotal clinical trial known as PLATO (PLATelet Inhibition and Clinical Outcomes), noting it was led by “a strong academic group.”

Neither AstraZeneca nor the DOJ have disclosed the exact nature of the investigation, but analysts believe the probe likely relates to aspects of the study that have been criticized by outside researchers. In a recent paper in the International Journal of Cardiology, James DiNicolantonio of Ithaca, New York, and Ales Tomek of Charles University in Prague, said that trial patients monitored by AstraZeneca were reported as benefiting more from taking Brilinta than those monitored by an independent clinical research organization.

Brilinta sales have been disappointing since the drug’s launch two years ago, according to Reuters, though AstraZeneca hopes that further clinical tests will underscore Brilinta’s value in preventing heart attacks. Brilinta works by preventing the formation of blood clots, thus maintaining blood flow to help reduce the risk of another cardiovascular event. Brilinta already carries a boxed warning that aspirin doses above 100 milligrams per day decrease the effectiveness of the medication.

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