This week, the FDA began its review of Brilinta, the blood thinner that has caused some controversy over its trial results, particularly in the United States.
Brilinta (ticagrelor), manufactured by AstraZeneca, is an antiplatelet drug that would be used to prevent heart attack and stroke in people with acute coronary syndrome. AstraZeneca submitted it for FDA approval based on the results of the phase III clinical trial PLATO (A Study of Platelet Inhibition and Patient Outcomes) from 2009, where the drug was compared with rival antiplatelet medication Plavix (clopidogrel), manufactured by Bristol Meyers Squibb and Sanofi-Aventis. The 18,624 participants in the trial took either Brilinta or Plavix with an aspirin. According to the trial results, Brilinta reduced the incidence of heart attack and stroke in patients by 11.7 percent compared to Plavix, which only reduced cardiovascular incidents by 9.8 percent.
However, this was not the case when only patients in North America were studied. Brilinta failed to beat Plavix in reducing the incidence of heart attack and stroke in the 1,400 North American trial participants. In fact, more patients experienced a cardiovascular event (3.8 percent with Brilinta compared to 3.2 percent with Plavix) on Brilinta than Plavix. The FDA organized an advisory committee to review Brilinta and the PLATO results and decide whether or not to recommend Brilinta for approval. On Wednesday, the panel recommended in a 7-1 vote that the FDA approve the drug.
Medical experts are not sure why the North American results were so different from the overall results. Some suspect that participants in North America were given higher doses of aspirin than participants in other parts of the world. Since the panel could not find enough evidence to explain the conflicting North America results, and since Brilinta had favorable results overall, the panel voted to recommend Brilinta be approved.
The advisory panel’s decision is not binding, and the FDA is not scheduled to make a final decision on approving Brilinta until September. The one panelist who voted against approval believes that AstraZeneca should conduct another study to address the North American results before the drug can be approved. Panelists also discussed the possibility of conducting a postmarket trial that would focus specifically on patients in the United States.
NPTA wants to know what pharmacy technicians think. Should the FDA go with the panel’s recommendation and approve Brilinta? Or should there be further study to explain the results in North America? Take the NPTA poll and post your comments on Facebook, Twitter or the comments section of this blog!
Tags: antiplatelet drugs, AstraZeneca, blood thinner, Brilinta, Brilique, Bristol Myers Squibb, cardiovascular, clinical trial, CPhT, FDA advisory committee, FDA advisory panel, heart attack, medications, NPTA, pharmacy, pharmacy technician, PLATO study, PLATO trial, Plavix, Sanofi, Sanofi-Aventis, stroke, ticagrelor










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