US government clears AstraZeneca’s Brilinta over concerns related to trial process

The US government has cleared UK drug giant AstraZeneca over concerns as regards its new heart drug, Brilinta's trial process.

The clinical trial had been the subject of investigation by the US Department of Justice over concerns that too many patients were sourced from eastern Europe for the study.

Further there were concerns from discrepancies in data reported by the drug manufacturers own lab and in comparison with studies by an independent trial. The US government yesterday said it was closing the probe and would take no further action.

City AM quoted Tom Keith-Roach, vice-president for the drug as saying it was frustrating to think of the patients who probably should have been receiving Brilinta for the last nine months but did not due to the cloud hanging over the drug.

According to AstraZeneca Brilinta, which was used to treat patients at risk from heart attack or stroke, could potentially be worth $3.5 billion a year, despite sales of just $216 million in the first half of 2014.

AstraZeneca said the DoJ  was closing the probe into the 18,000-patient study and no further action was planned, Reuters reported.