How brilliant is Brilinta?

AstraZeneca US drug trial queriedAstraZeneca's chief executive Pascal Soriot says he is very confident in the findings of the clinical trial of heart drug Brilinta. Photograph: Lynne Cameron/PAAstraZeneca is being investigated by US authorities over a clinical trial that was used to win marketing approval for its heart drug Brilinta, casting fresh doubts over the medicine.Brilinta sales have been a disappointment since its launch two years ago, although AstraZeneca has recently stepped up marketing efforts and hopes that further clinical tests will underscore its value in preventing heart attacks.The British drugmaker said on Thursday it received a civil investigative demand from the US department of justice, seeking documents and information regarding the Plato (platelet inhibition and patient outcomes) study.AstraZeneca plans to co-operate with the DOJ and its chief executive, Pascal Soriot, said he was "very confident" in the findings of the trial. "It was guided by a strong academic group who oversaw the trial and its conduct," he told reporters after announcing third-quarter results.AstraZeneca did not disclose the exact nature of the investigation and DOJ spokesman Peter Carr in Washington said he had no immediate comment on the case.The results of the 18,000-patient trial were first reported in 2009 and went on to form the basis of successful new drug applications in the US, Europe and other markets. Brilinta was launched in 2011.Aspects of the study, which r...
Source: PharmaGossip - Category: Pharma Commentators Authors: Source Type: blogs