AstraZeneca Replies To The US FDA Complete Response Letter For BRILINTA (Ticagrelor Tablets)

AstraZeneca announced today it has replied to the US Food and Drug Administration’s (FDA) Complete Response Letter (CRL) received for the ticagrelor (BRILINTA) New Drug Application (NDA) 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 between high dose aspirin and ticagrelor are viable explanations for the efficacy differences observed in a subset of US patients in the PLATO trial.

The CRL did not request that additional studies, including clinical studies, be conducted as a prerequisite for approval of the ticagrelor NDA.

According to the FDA’s published guidance, following the issuance of a CRL, resubmitted NDAs, once accepted by the FDA, are given one of two classifications: Class 1 starts a two-month review cycle while Class 2 starts a six-month review.

The FDA will now review AstraZeneca’s response to determine whether the information submitted is complete and whether to designate the review as Class 1 or Class 2.

AstraZeneca remains confident in the NDA submission for ticagrelor and will continue to work with the FDA to progress towards the completion of the review of the NDA for ticagrelor.