FDA issues CRL for AstraZeneca's ticagrelor NDA

AstraZeneca (NYSE: AZN) announced today 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.

SOURCE AstraZeneca