Anglo-Swedish drug major AstraZeneca (LSE: AZN) announced this morning that the European Commission has granted marketing authorization for its blockbuster potential oral blood thinning drug candidate Brilique (ticagrelor) for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (ACS).
This decision follows the positive opinion from the Committee for Medicinal Products for Human Use (The Pharma Letter September 26) and is applicable to the 27 European Union member states and the three European Economic Area countries of the European Union. Ticagrelor is still under review at the US Food and Drug Administration, which has extended the Prescription Drug User Fee Act (PDUFA) date for approving the drug - to be known as Brilinta in the USA - from September 16 to December 16, 2010.
Annual sales of $2.3 billion forecast
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