AstraZeneca said today that the FDA had accepted its resubmission of the ticagrelor (Brilinta) NDA and had set a deadline of July 20, 2011 to reach a decision. As previously reported, on December 16 the FDA issued a Complete Response Letter to the initial ticagrelor NDA. Although ticagrelor received a favorable response from the FDA Cardiovascular and Renal Advisory last summer, the lack of benefit seen in patients treated in the US in the PLATO trial has remained a stumbling block for the drug’s approval.
Here is the press release from AstraZeneca:
US FDA assigns new PDUFA date for BRILINTA (ticagrelor tablets)
Friday, 4 February 2011
AstraZeneca announced today that the US Food and Drug Administration (FDA) has acknowledged receipt of the company’s reply to the Complete Response Letter (CRL) for the ticagrelor New Drug Application (NDA). Accordingly, the agency has accepted AstraZeneca’s resubmission of the ticagrelor NDA, categorised it as a Class 2 resubmission to the CRL, and set a new PDUFA date of 20 July 2011.
The FDA issued the CRL on 16 December 2010. On 21 January 2011, AstraZeneca announced it had submitted the requested supplementary analyses as part of its CRL response.
AstraZeneca remains confident in the NDA submission for ticagrelor and will continue working with the FDA to progress towards completing the review of the NDA for ticagrelor.
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 21 countries, including the US. The product has been approved in 30 countries, including in the EU, Iceland, and Norway, under the trade name BRILIQUE and in Brazil under the trade name BRILINTA.
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 improve cardiovascular (CV) outcomes in ACS patients, compared to clopidogrel. The NDA submission for ticagrelor is based on the results of a comprehensive clinical trial programme, including data from the PLATO study.
The Prescription Drug User Fee Act (PDUFA) allows the FDA to collect fees from companies that produce certain human drug and biological products, including when an NDA is submitted. It is usual for the FDA to set a PDUFA goal date when responding to an NDA.
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 $33.3 billion in 2010. For more information please visit: www.astrazeneca.com