PLATOnic Dialog

A complete response letter for AstraZeneca plc's Brilinta ticagrelor signals that FDA and the company are still trying to solve the problem the agency posed to an advisory committee in July: what is the explanation for lower efficacy in the U.S. subgroup of the global PLATO study. That's not a problem in Europe, where the company is preparing to launch the drug to prevent atherothrombotic events in acute coronary syndrome.

FDA's request for additional analyses of the PLATO data came a week after the EC granted marketing authorization for ticagrelor plus aspirin. The reversible adenosine diphosphate (ADP) receptor (P2Y12) antagonist will be sold in Europe as Brilique...