Navigation Links
AstraZeneca Receives Complete Response Letter From US FDA For BRILINTA™ (Ticagrelor Tablets)

WILMINGTON, Del., Dec. 16, 2010 /PRNewswire/ -- 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.


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.

About AstraZeneca

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: or call 1-800-AZandMe (292-6363).

SOURCE AstraZeneca
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Abbott and AstraZeneca Announce Selection of Next-Generation Fenofibrate ABT-335 and CRESTOR(R) Fixed-Dose Combination
2. New Analysis of METEOR Study Demonstrate Effects of AstraZenecas CRESTOR(R) (Rosuvastatin Calcium) on Atherosclerosis in Patients With Two or More Risk Factors for Cardiovascular Disease
3. AstraZeneca Completes Enrollment in First Phase III Study of the Investigational Drug Vandetanib (ZACTIMA)(R) in Non-Small Cell Lung Cancer
4. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
5. AstraZeneca Submits an sNDA for SYMBICORT(R) for COPD Indication
6. Volcano Announces Participation in SATURN Clinical Trial Sponsored by AstraZeneca
7. AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines
8. Daiichi Sankyo/Eli Lillys Effient and Astrazenecas Ticagrelor May Offer Advantages in the Treatment of Post-Myocardial Infarction
9. AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication
10. Phase III Study of Abbotts Investigational TriLipix(TM) in Combination With AstraZenecas CRESTOR(R) Meets Primary Endpoints on Key Lipids
11. AstraZeneca Submits an sNDA for SYMBICORT(R) for the Treatment of Asthma in Children as Young as Age Six
Post Your Comments:
(Date:11/26/2015)... , November 26, 2015 ... addition of the "Radioimmunoassay Market by ... (Hospital, Pharmaceutical Industry, Academics, Clinical Diagnostic Labs), ... Global Forecast to 2020" report to ... has announced the addition of the ...
(Date:11/25/2015)... 25, 2015  Amgen (NASDAQ: AMGN ) today ... with the United States (U.S.) ... biosimilar candidate to Humira ® (adalimumab). Amgen believes ... to the FDA and represents Amgen,s first BLA submission ... Harper , M.D., executive vice president of Research and ...
(Date:11/25/2015)... On Tuesday, November 24, 2015, the ... Wright Medical Technology, Inc. for product liability and ... implant device, awarded $11 million in favor of ... and three days of deliberations, the jury found ... designed and unreasonably dangerous, and that Wright Medical ...
Breaking Medicine Technology:
(Date:11/28/2015)... Aliso Viejo, CA (PRWEB) , ... November 28, 2015 , ... ... 30 new fully customizable media panels to choose from, the possibilities are endless. Users ... angle, and more. With the ProPanel: Pulse masking effects, users are sure to get ...
(Date:11/27/2015)... CO (PRWEB) , ... November 27, 2015 , ... According ... cities are not changing the way that they are handling security in light of ... police and security presence in an attempt to stop an attack from reaching U.S. ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... were," said an inventor from Hillside, N.J. "Many people catch diseases simply from ... that individuals will always be protected from germs." , He developed the patent-pending ...
(Date:11/27/2015)... ... , ... MPWH, the No.1 Herpes-only dating community in the world, revealed that over 50% of ... than 3.7 billion people under the age of 50 – or 67% of the population ... global estimates of HSV-1 infection . , "The data shocks us highly!" said Michelle ...
(Date:11/27/2015)... , ... November 27, 2015 , ... ... Secura Consultants has prided itself for not only fulfilling the needs of advisers ... solutions at an affordable price and providing top-tier customer service. However, there's always ...
Breaking Medicine News(10 mins):