Health Canada has approved AstraZeneca's (AZ) Brilinta (ticagrelor) for the secondary prevention of atherothrombotic events, such as blood clots, in patients with acute coronary syndrome.
The approval comes seven months after the drug was denied approval by the US Food and Drug Administration (FDA), with studies demonstrating that patients were more likely to experience heart problems with Brilinta than rival drug Plavix (clopidogrel), despite AZ's treatment having greater efficacy.
The FDA did not request additional studies, but did ask for additional analyses of the data from the company's PLATO trial. The drug remains in review in the US, as well as Russia, India and China.
Including Canada, Brilinta has now been approved in 33 countries, including in the European Union under the name Brilique.
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