Pharmaceutical Business review

US DoJ clears AstraZeneca’s clinical trial

AstraZeneca was hit with claims from outside medical professionals that it reportedly had rigged PLATO clinical trials involving 18,624 patients in 43 nations, in a bid to furnish positive results to seek approval.

AstraZeneca chief executive officer Pascal Soriot said: "We welcome the Department of Justice’s decision not to pursue further action.

"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."

According to the company, the blood-thinning Brilinta drug would be effective in a number of patients in addition to its current acute coronary syndrome patients.

The company has recently started the SOCRATES trial, which involves studying Brilinta for patients with acute ischemic stroke or transient ischemic attack, and the THEMIS study in patients with Type 2 diabetes and coronary atherosclerosis.

Both the studies form part of PARTHENON, which is AstraZeneca’s largest ever clinical trial programme, involving over 80,000 patients globally.

Further, the programme also involves two trials including EUCLID for patients with Peripheral Artery Disease and PEGASUS involves studying Brilinta for secondary prevention in patients with prior myocardial infarction.