The approval of a new antiplatelet drug which will eventually become a competitor with clopidogrel (Plavix) has been delayed by the Food and Drug Administration (FDA). The new drug, ticagrelor, was recently approved in Europe. The drug has received quite a bit of coverage in the lay press here in the U.S.
The FDA has asked for further evaluation of the PLATO trial which is a study conducted on 18,000 patients in 43 countries around the world to evaluate the new drug. In the 1,814 patients studied in the U.S. and Canada the outcome was worse in the patients taking ticagrelor as compared to clopidogrel (Plavix).
A spokesperson for drug company AstraZeneca says that the company remains confident that the drug will be approved. bjmdjd
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