Concerns about clinical trial problems involving Brilinta have extended to European regulators, who are now asking questions about AstraZeneca’s handling of the blood thinner after the company disclosed that the U.S. Department of Justice (DOJ) has launched a probe.
On Thursday, the European Medicines Agency (EMA) announced that it had contacted AstraZeneca for more information on the DOJ investigation. The request also comes amid recent accusations that the company downplayed or outright hid information about the possible risk of Brilinta heart problems.
Earlier this month, AstraZeneca announced that the DOJ had launched an investigation into questionable clinical trials involving Brilinta. While no specifics about the nature of the investigation were revealed by the company, the probe comes following a recent report that identified a number of irregularities involving a clinical trial and suggested that reports of heart attacks linked to Brilinta may have been under-reported.
In August, a study published in the International Journal of Cardiology suggested that AstraZeneca may have manipulated data during an 18,000-patient clinical trial to make the drug appear safe when data suggested otherwise. Among the irregularities was the fact that an independent review of the data found that 46% of all primary endpoint events favoring Brilinta came from just two countries, Poland and Hungary, despite the participation of subjects from numerous other countries. The review also found that heart attacks linked to Brilinta were under-reported in the clinical trial findings.
The trial, known as PLATO, was used to get Brilinta approved for the market in 2011. The company had hoped to make the drug one of its flagship medications, but to date sales have been disappointing.
Just last month, a study was presented at the European Society of Cardiology, where researchers from the Netherlands warned that a significant number of patients are dropping the drug due to side effects of Brilinta, which include breathlessness and other health problems.
Brilinta (ticagrelor) is a type of blood thinner known as a platelet aggregation inhibitor. It was developed by AstraZeneca and approved by the FDA in July 2011. It carries a black box warning for bleeding risks, similar to that of other blood thinners.