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news.The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to AstraZeneca for the new drug application (NDA) for Ticagrelor (Brilinta).
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Brilinta is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclopentyltriazolopyrimidines (CPTPs).
In the CRL, the FDA requested additional analyses of the Plato data.
Plato was a head-to-head patient outcomes study of Ticagrelor versus clopidogrel, designed to establish whether Ticagrelor could achieve clinically meaningful cardiovascular and safety end points in ACS patients, above and beyond those afforded by clopidogrel.
AstraZeneca said that the agency did not request that additional studies, including clinical studies, be conducted as a prerequisite for approval of the Ticagrelor NDA.
AstraZeneca is evaluating the contents of the CRL and will respond to the agency’s request for additional analyses of the Plato data as soon as possible.
The company remains confident in the NDA submission for Ticagrelor and in its ability to respond to the agency’s questions.
AstraZeneca Research & Development president Martin Mackay their priority is to provide the requested Plato analyses to the FDA and progress to completion of the Brilinta NDA review.