Experts Support FDA Panel's Backing of New Blood Thinner

Brilinta, which got nod from agency advisors Wednesday, would be welcome option, docs say

By Steven Reinberg
HealthDay Reporter

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THURSDAY, July 29 (HealthDay News) -- Following a federal health panel's endorsement of the new blood thinner Brilinta Wednesday, cardiologists say the drug could be a welcome addition to treatments for heart patients.

In a 7-to-1 vote, the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee recommended approval of the drug for heart patients undergoing angioplasty or stenting to open blocked arteries, and for those not requiring such interventions but being managed with drug therapy alone.

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The panel's nod was partly based on the results of a clinical trial, called PLATO, that pitted ticagrelor (Brilinta) against the current standard anticoagulant, clopidogrel (Plavix).

In that trial, Brilinta was found to be more effective than Plavix, with similar risks, for patients with acute coronary syndrome. The syndrome covers a variety of symptoms, from chest pain to heart attack.

While the FDA does not have to abide by the committee's recommendations, it usually does. According to the Dow Jones news service, the agency is expected to make a final decision on the drug by Sept. 16.

"Brilinta is an oral, direct-acting and reversible inhibitor of receptors on platelets," blood cells that aid in clotting, explained Dr. Gregg C. Fonarow, director of the Ahmanson-UCLA Cardiomyopathy Center at the University of California, Los Angeles. Like Plavix, Brilinta works by keeping platelets from sticking together and forming potentially dangerous clots.

"It has a more rapid onset and more pronounced effect at inhibiting platelets than Plavix," Fonarow added.

Another expert said an advantage of Brilinta over Plavix is its ability to be metabolized by all patients.

"One problem with Plavix is some small percentage of the population are what's called slow metabolizers on a genetic basis," Robert J. Myerburg, a professor of medicine and physiology in the Cardiovascular Division at the University of Miami Miller School of Medicine. "Their gene makeup is such that they don't metabolize Plavix as the majority of the population [does]."

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