US clears Astrazeneca over trial data for new heart drug Brilinta
British drug giant Astrazeneca has been cleared by the US government over concerns about the trial process for its new heart drug Brilinta.
The American department of justice was investigating the clinical trial conducted by Astrazeneca over concerns that too many patients were sourced from eastern Europe for the study.
Perceived discrepancies in data reported by the drug manufacturers own lab and compared to studies by an independent trial were also cited as concerns. Yesterday the US government said it was closing the probe and would take no further action.
“It’s frustrating to think of the patients who probably should have been receiving Brilinta for the last nine months but potentially didn’t because of this cloud hanging over the brand,” said Tom Keith-Roach, vice-president for the drug.
Astrazeneca believes Brilinta, which is used to treat patients at risk from heart attack or stroke, could potentially be worth $3.5bn (£2.1bn) a year, despite sales of just $216m in the first half of 2014.