Brilinta ticagrelor regulatory update

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 7-1 on Wednesday to recommend approval of Brilinta ticagrelor from AstraZeneca to reduce thrombotic events in patients with acute coronary syndrome (ACS). The panelists largely agreed that if approved, a U.S. postmarketing study should be required to determine what caused the regional efficacy differences in the Phase III PLATO trial of Brilinta compared to Plavix clopidogrel. Brilinta performed worse than Plavix on the trial's primary endpoint of time to first occurrence of any event from the composite of cardiovascular death, myocardial infarction and stroke in the U.S. (n=1,413; 12.6% vs. 10.1%, p=0.146). However, the trial met the primary endpoint across all 43 countries involved (n=18,624; 9.8% vs. 11.7%, p<0.0001).

The panel was divided on whether the label's claim should include reduction of stent thrombosis, although there was not a formal vote on the subject. Panelists also requested certain clarifications be included on the label, such as recommending against concomitant high-dose aspirin and noting that strokes and intracranial hemorrhages were numerically higher with Brilinta than with Plavix. ...