Brilinta

Treatment for Acute Coronary Syndrome

Update: Brilinta (ticagrelor) Now FDA Approved - July 20, 2011

US Food and Drug Administration Extends Review Timeline For Brilinta (Ticagrelor) New Drug Application

LONDON, 15 September 2010 - AstraZeneca today announced that the US Food and Drug Administration (FDA) has extended the time to complete its review of the New Drug Application (NDA) for ticagrelor (Brilinta).

Accordingly, the FDA extended the Prescription Drug User Fee Act (PDUFA) date from 16 September 2010 to 16 December 2010. AstraZeneca will continue to work closely with the FDA to support the review of the ticagrelor NDA.

Ticagrelor is currently under regulatory review in nine additional territories around the world, including the European Union, Canada, and Brazil.

About Brilinta/Brilique

Ticagrelor (Brilinta/Brilique) is an investigational oral antiplatelet treatment for Acute Coronary Syndromes (ACS). Ticagrelor is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Ticagrelor is the first reversibly-binding oral ADP receptor antagonist.

Brilinta and Brilique are trademarks of the AstraZeneca group of companies.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation 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


CONTACTS:

Media Enquiries:
Neil McCrae +44 20 7604 8236 (24 hours)
Chris Sampson +44 20 7604 8031 (24 hours)
Sarah Lindgreen +44 20 7604 8033 (24 hours)
Abigail Baron +44 20 7604 8034 (24 hours)

Investor Enquiries UK:
Jonathan Hunt +44 20 7604 8122 mob: +44 7775 704032
Karl Hård +44 20 7604 8123 mob: +44 7789 654364
Clive Morris +44 20 7604 8124 mob: +44 7710 031012

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

Posted: September 2010

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Brilinta (ticagrelor) FDA Approval History

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