AstraZeneca Remains Confident in the NDA Submission for Ticagrelor
AstraZeneca says it remains confident in the NDA submission for ticagrelor and will continue to work with the FDA to progress towards the completion of the review.
AstraZeneca announced that it has replied to the US FDA Complete Response Letter (CRL) received for the ticagrelor New Drug Application on 16 December 2010.
The additional analyses of the PLATO trial requested in the CRL focused primarily on interactions between ticagrelor and high dose aspirin. AstraZeneca believes these supplementary analyses support the hypothesis that the apparent difference in treatment effect observed in the US and non-US patient subsets in PLATO is most likely a reflection of an underlying interaction between ticagrelor and higher doses of aspirin.
AstraZeneca remains of the view that either the play of chance or an interaction
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