When the U.S. Department of Justice (DOJ) opens a probe into a specific drug — especially one as potentially lucrative as AstraZeneca’s Brilinta —pharmaceutical companies are often left scrambling. But AstraZeneca is breathing a huge sigh of relief today, as the DOJ has cleared the company of any wrongdoing in conducting clinical trials.
The DOJ announced that it was closing a probe into Brilinta that it had opened in October 2013. The department had been trying to determine whether a major clinical trial called PLATO had been fairly conducted.
PLATO was a study consisting of 18,624 patients in 43 countries, comparing the effects of Brilinta to clopidrogel (marketed as Plavix by Sanofi SA before it went off patent in 2012). According to the study, patients taking Brilinta plus aspirin suffered fewer instances of heart attack, stroke or death from vascular causes.
However, Dr. Victor Serebruany, an adjunct medical professor at Johns Hopkins Hospital, wrote in a complaint to the U.S. district court in the District of Columbia that he believed the numbers in the study had been manipulated. In particular, he asked the DOJ to probe the number of deaths in the group taking clopidrogel, which he believed to be artificially high.
In clearing the PLATO study, the DOJ has preserved a key drug in AstraZeneca’s arsenal. One of the five “platforms” that the company is using to drive sales growth, AstraZeneca used Brilinta as just one example of why it was rejecting Pfizer’s proposed takeover bid from early 2014.
“We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefits Brilinta offers to patients around the world,” AstraZeneca CEO Pascal Soriot said in a statement to the Wall Street Journal.
Sales of Brilinta came in at $114 million for the second quarter of 2014. However, the company is hoping to expand the drug’s reach, conducting another study of 80,000 patients to see whether the drug can be used for patients with a specific type of heart attack or stroke.