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news.British drug maker Astrazeneca has received the US Food and Drug Administration (FDA) approval for Brilinta (ticagrelor) tablets as a treatment for acute coronary syndrome (ACS).
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Brilinta is indicated to reduce unstable angina, non-ST-elevation myocardial infarction or ST-elevation myocardial infarction in patients with ACS.
The FDA approval was given on the basis of the positive results from platelet inhibition and patient outcomes (PLATO) study, which evaluated Brilinta versus clopidogrel in ACS patients globally.
In the study, the difference in treatment benefit versus clopidogrel was seen at 30 days and the Kaplan-Meier survival curves continue to diverge throughout the 12 month treatment period.
Currently, Brilinta has been approved in around 39 countries and is under regulatory review in approximately 45 countries.