Although Brilinta performed well in a supervised clinical trial, how it will perform when made available to thousands of patients remains unknown, Borer said. "If you put the drug out into general use, we don't really know for sure that the safety results will be exactly the same in general use as they were in a monitored trial," he said.
While the safety of Brilinta is the same as Plavix for major bleeding, there are some side effects associated with Brilinta that were not seen with Plavix, Borer said.
These include difficulty breathing and a heart rhythm problem called heart block. Both these conditions occurred in few patients and can be treated, the expert said.
"On balance, Brilinta is sufficiently safe for its intended use and has greater efficacy than the drug that is the standard for use," Borer said.
"Brilinta offers great promise without increase in important safety risks and that's why the drug is probably going to be a very useful addition to the armamentarium of doctors taking care of patients with acute coronary syndrome and related problems," he said.
The cost of brand-name Brilinta compared to Plavix (which is now available in a cheaper generic version) may be a big issue, however. According to Borer, "although efficacy and safety considerations are certainly first, given the fact that third parties are paying for these drugs, they may not be willing to pay for the drug in certain situations, but that remains to be determined."
In a statement, AstraZeneca's chief medical officer Dr. Howard Hutchinson, said the company is "pleased with the Advisory Committee's recommendation to support the approval of ticagrelor. We look forward to continued discussions with the FDA as it evaluates the panel's recommendation and completes its review of the new drug ap
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