AstraZeneca receives complete response letter from US FDA for BRILINTA (ticagrelor tablets)
Friday, 17 December 2010
AstraZeneca 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.
NOTES TO EDITORS
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 eighteen territories around the world and was granted marketing authorization under the trade name BRILIQUE™ by the European Commission (EC) on December 6, 2010.
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 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. For more information please visit: www.astrazeneca.com.
Media Enquiries UK
Neil McCrae +44 20 7604 8236 (24 hours)
Sarah Lindgreen +44 20 7604 8033 (24 hours)
Abigail Baron +44 20 7604 8034 (24 hours)
Media Enquiries US
Julia Walker +1 302 885 5172 mob: +1 610 350 8240
Kate Childress +1 302 885 8217 mob: +1 302 290 7242
Investor Enquiries UK
Jonathan Hunt +44 20 7604 8122 mob: +44 7775 704032
Karl Hård +44 20 7604 8123 mob: +44 7789 654364
Investor Enquiries US
Ed Seage +1 302 886 4065 mob: +1 302 373 1361
Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043