AstraZeneca 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.
About BRILINTA (ticagrelor tablets)
BRILINTA is an oral antiplatelet treatment for acute coronary syndromes (ACS). BRILINTA is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA is the first reversibly-binding oral ADP receptor antagonist.
BRILINTA is currently under regulatory review in 21 countries, including in the US. The product has been approved in 30 countries, including in the EU, Iceland, and Norway, under the trade name BRILIQUE and in Brazil under the trade name BRILINTA.
BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of companies.
About the PLATO study
PLATO was a large (18,624 patients in 43 countries) head-to-head patient outcomes study of ticagrelor versus clopidogrel, designed to establish whether ticagrelor could improve cardiovascular (CV) outcomes in ACS patients, compared to clopidogrel. The NDA submission for ticagrelor is based on the results of a comprehensive clinical trial programme, including data from the PLATO study.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009.