Ticagrelor FDA Approval Issues Revisited

<b><i>Context:</i></b> On July 20, 2011, the Food and Drug Administration (FDA) approved ticagrelor (Brilinta™) for use during acute coronary syndromes. The drug labeling includes a ‘black box’ warning for bleeding risks, conventional for antithrombotics, and a unique warning that higher than 100 mg/daily maintenance treatment with aspirin may reduce ticagrelor effectiveness. The approval was granted following ticagrelor secondary reviews, and review of complete response by FDA officials. <b><i>Objective:</i></b> To summarize the recommendations of different FDA reviewers, and their impact on drug approval. <b><i>Design, Setting, and Patients:</i></b> Review of the Platelet Inhibition and Clinical Outcomes (PLATO) trial comparing the efficacy of ticagrelor versus standard care treatment with clopidogrel. Patients (n = 18,624) with moderate- to high-risk acute coronary syndromes undergoing coronary intervention or being medically managed were randomized to ticagrelor (180-mg loading dose followed by 90 mg twice daily thereafter) or clopidogrel (300–600-mg loading dose followed by 75 mg once daily) for 6–12 month