The U.S. Department of Justice today announced they are concluding their investigation into a clinical trial for AstraZeneca's Brilinta (ticagrelor), a drug prescribed for patients with acute coronary syndrome. Federal officials first issued a request in October 2012 to AstraZeneca for documents and other information after accusations were made by outside medical experts that AstraZeneca had rigged the clinical trial -- known as PLATO -- that involved 18,624 patients in 43 countries in order to provide favorable results in their efforts to seek approval.
After reviewing initial results of the study, a number of outside researchers reported that patients enrolled in the clinical trial at sites run and monitored by the pharmaceutical company had more positive outcomes from taking the blood thinner than those who were being monitored by outside researchers.
"We welcome the Department of Justice's decision not to pursue further action," said Pascal Soriot, chief executive officer of AstraZeneca, said in a statement. "We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefit Brilinta offers to patients around the world suffering from acute coronary syndrome. As one of AstraZeneca's growth platforms, we are committed to delivering the full potential of this important medicine."
The initial, favorable results of the trial were presented at the European Society of Cardiology and also published in the New England Journal in 2009. The researchers found patients with acute coronary syndrome who took the drug along with low-dose aspirin significantly reduced their risk for death from related causes. Overall the drug was found to be more effective than clopidogrel, which is generic of Plavix -- the main competition for AstraZeneca's drug.
In a paper published online in the International Journal of Cardiology in 2013 that addressed the problems with the clinical trial, two doctors, James DiNicolantonio and Ales Tomek, wrote: "The FDA report highlights what appear to be multiple serious deficiencies in the reporting of the PLATO results, which clinicians will not have gleaned from the primary publication alone. Individual clinicians may therefore wish to carefully reconsider their practice of ticagrelor prescription for this indication. Guideline bodies should also evaluate the information in its totality."
Brilinta initially earned approval from the U.S. Food and Drug Administration in 2011 for the use of patients with acute coronary syndrome, which is any condition precipitated by a reduced blow flow to the heart. The drug works by stopping the formation of blood clots that obstruct circulation and can cause cardiac arrest and strokes. Brilinta has been approved in more than 100 countries. Executives project the drug will bring in as much as $3.5 billion by 2023.
AstraZeneca recently announced plans to begin additional clinical trials to test the efficacy and safety of Brilinta's use for other indications: to manage transient ischemic attack (a trial known as SOCRATES), as well as patients with a co-morbidity of type 2 diabetes and coronary atherosclerosis (a trial known as THEMIS). These studies are part of a larger clinical trial program that involves more than 80,000 patients throughout the world.