LONDON, Oct 31 (Reuters) - AstraZeneca is being investigated by U.S. authorities over a major clinical trial that was used to win marketing approval for its new heart drug Brilinta.
The British drugmaker said on Thursday it had received a civil investigative demand from the U.S. Department of Justice seeking documents and information regarding the so-called PLATO study.
AstraZeneca, which highlighted the investigation in its quarterly results statement, gave no further details but said it intended to cooperate with the inquiry.
Brilinta is a key new product for the company, although its progress to date has been slow, with sales in the third quarter edging up to $75 million from $65 million in the three months to end-June.
A key challenge for Brilinta is the fact that U.S. doctors tend to use high-dose aspirin for cardiovascular patients and clinical trials suggest AstraZeneca’s new drug does not work as well in this setting.