12/20/2010

The FDA issued a complete-response letter for Brilinta, a blood-thinning agent from AstraZeneca. The agency did not request additional tests but asked the company to undertake further analysis of clinical data from a pivotal trial, PLATO. The regulatory delay "suggests there remains some degree of controversy with the fact that in the U.S. subset of PLATO patients, Brilinta was shown to be worse than Plavix, in contrast to the worldwide data set that showed Brilinta was better than Plavix," an analyst said.

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