AstraZeneca announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for ticagrelor (Brilinta).
In the CRL, the FDA requested additional analyses of the Plato data. 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.
“Our highest priority is to provide the requested Plato analyses to the FDA and progress to completion of the Brilinta NDA review,” said Martin Mackay, president, research & development, AstraZeneca.
Brilinta is an oral anti-platelet 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 eighteen territories around the world and was granted marketing authorization under the trade name Brilique by the European Commission (EC) on December 6, 2010.
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 achieve clinically meaningful cardiovascular and safety end points in ACS patients, above and beyond those afforded by clopidogrel. The NDA submission for ticagrelor is based on the results of a comprehensive clinical trial program, including data from the Plato study.
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization 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.