NDA expected to be submitted in 4Q09; statistically significant primary efficacy endpoint vs. clopidogrel in prevention of CV events in patients with ACS (5/09); PLATO study published in NEJM demonstrates that ticagrelor achieved greater efficacy in reduction of CV events (primary endpoint) vs. clopidogrel w/out an increase in major bleeding (8/09); in subanalysis of PLATO, ACS STEMI patients using Brilinta showed a reduction of CV events for up to a year w/out an increase in major bleeding 11/09; NDA submitted 11/09; patients with planned stenting for ACS had fewer CV events than patients who received clopidogrel, as reported 1/10; Brilinta shown to be effective in clopidogrel non-responders (3/10); FDA advisory board scheduled for 7/28/10; FDA advisory board recommends drug 7/10; PDUFA on 9/16/10
Brand Brilinta Generic ticagrelor (AZD6140)
Company name AstraZeneca Product type Non-speciality
Therapeutic category Cardiovascular agents Key uses acute coronary syndromes
Other Uses n/a Drug Class antiplatelet drug; reversible oral adenosine diphosphate (ADP) receptor antagonist
Dosage From oral Expected Approval 2010-Q3
FDA Filing 11/09 Last Update date September 01,2010
Link to pipeline report
Link to news article
Link to published data
Link to clinicaltrials.gov
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