FDA Requests Further Analysis for Ticagrelor
December 17, 2010 - The U.S. Food and Drug Administration (FDA) has requested additional analyses of the trial data in its review of the new antiplatelet agent ticagrelor (Brilinta).
The FDA issued a complete response letter for AstraZeneca’s new drug application for ticagrelor. In the letter, 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.
Ticagrelor is an oral antiplatelet treatment for acute coronary syndromes (ACS). The drug is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclopentyltriazolopyrimidines (CPTPs). The agent is the first reversibly-binding oral ADP receptor antagonist.
It 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 Dec. 6.
PLATO was a large study of 18,624 patients in 43 countries comparing ticagrelor to clopidogrel (Plavix). It was 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 submission for ticagrelor is based on the results of a comprehensive clinical trial program, including data from the PLATO study.
For more information: www.astrazeneca-us.com
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