BrilintaTreatment for Acute Coronary Syndrome
Update: Brilinta (ticagrelor) Now FDA Approved - July 20, 2011
Complete Response Letter for Brilinta NDA
AstraZeneca Receives Complete Response Letter From US FDA For Brilinta (ticagrelor Tablets)
WILMINGTON, Del., Dec. 16, 2010 /PRNewswire/ -- 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.
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. In the United States, AstraZeneca is a $14.8 billion healthcare business.
For more information about AstraZeneca in the US or the AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
CONTACT: Neil McCrae, +44-20-7604-8236 (24 hours), Sarah Lindgreen, +44-20-7604-8033 (24 hours), Abigail Baron, +44-20-7604-8034 (24 hours), Julia Walker (US), +1-302-885-5172, mob: +1-610-350-8240, Kate Childress (US), +1-302-885-8217, mob: +1-302-290-7242; Investor Enquiries UK: Jonathan Hunt, +44-20-7604-8122, mob: +44-7775-704032, Karl Hard, +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
Web Site: http://www.astrazeneca-us.com
Posted: December 2010
- FDA Approves New Crushing Option for the Administration of Brilinta - March 30, 2015
- FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes - July 20, 2011
- US FDA Assigns New PDUFA Date for Brilinta (ticagrelor tablets) - February 4, 2011
- AstraZeneca Replies to the US FDA Complete Response Letter for Brilinta (Ticagrelor Tablets) - January 21, 2011
- US Food and Drug Administration Extends Review Timeline For Brilinta (Ticagrelor) New Drug Application - September 15, 2010
- FDA Advisory Committee Recommended US FDA Approval of Brilinta (Ticagrelor) for Acute Coronary Syndromes - July 29, 2010
- AstraZeneca Submits US New Drug Application for ticagrelor (Brilinta), an Investigational Antiplatelet Agent - November 19, 2009