FDA Panel Backs Heart Drug Multaq
The drug Multaq should be approved for sale in the United States to treat the common heart rhythm disorder atrial fibrillation, a Food and Drug Administration advisory panel recommended Wednesday.
In 2006, the FDA rejected Multaq due to a study that found the drug increased the risk of death and cardiovascular problems. Drug maker Sanofi-Aventis SA was told to conduct an additional study, The Wall Street Journal reported.
The new study found that patients taking Multaq had a 24 percent decrease in the combined risk of hospitalization for heart problems and death from any cause. Last year, Sanofi resubmitted its application for FDA approval of the drug.
In a 10-3 vote, the panel of outside medical experts recommended FDA approval of Multaq, the newspaper reported. The FDA isn't required to approve the drug, but generally follows its advisory panels' recommendations.
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