Probe Closed on AstraZeneca's Heart Drug; All Clear for Brilinta

Aug 19, 2014

Wall Street Journal

The U.S. Department of Justice has closed its investigation into AstraZeneca's heart drug Brilinta, which was launched last October when a key clinical trial was questioned.

Brilinta, which was approved in the U.S. in 2011, was called into question when a medical professor claimed that numbers in a clinical trial that compared Brilinta to Sanofi's Plavix were manipulated. The 18,624 patient global study showed patients taking Brilinta plus aspirin suffered fewer instances of heart attack, stroke or death from vascular causes over the course of a year than those on Plavix plus aspirin. However in the U.S. arm of the trial, Brilinta did worse than Plavix, which medical reviewers attributed to the higher-doses of aspirin taken by U.S. patients.

The investigation could have meant additional warnings or even a market withdrawl for AstraZeneca's blockbuster-hopeful, but the company announced today that it had received confirmation from the Justice Department that it is closing the investigation with no further action planned.

Read the WSJ article