REGULATORY NEWS

AstraZeneca submits ticagrelor for FDA approval

Written by Editorial Staff   
November 20, 2009
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AstraZeneca has submitted its antiplatelet drug, ticagrelor (Brilinta) to the FDA for approval via a new drug application.

Ticagrelor, used to help reduce major cardiac events in patients with acute coronary syndrome (ACS), would be the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist available on the U.S. market, according to the company.

AstraZeneca said its submission is based on results of the PLATO study, with data measuring platelet inhibition and patient outcomes comparing ticagrelor with aspirin and clopidogrel (Plavix) with aspirin.

Researchers have found ticagrelor to have “statistically significant primary efficacy endpoints versus clopidogrel” for helping decrease cardiovascular events in ACS patients.

Last updated on November 20, 2009 at 3:41 pm EST