An FDA expert panel has unanimously turned thumbs down on Solvay's tedisamil for atrial fibrillation. The experts said they would need more and better data before they could change their decision. Solvay says it will continue to work with regulators. The key problem, says the panel, is that the trial data indicates only a narrow dosage range that could be safe and effective. Serious side effects were noted for the high dosage and lower doses were less effective in treating the condition.
"It's almost like throwing a dart (to determine) what the dose should be," Tom Marciniak, medical team leader at FDA's cardiovascular and renal unit, told the advisory panel. "What will really happen to this drug when it's put out into the real world?"
- check out this release
- read the AFX report for more
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