FDA c'ttee says "no" to tedisamil approval

The US Food and Drug Administration's Cardio-Renal Advisory Committee has voted unanimously against the approval of tedisamil for the treatment of atrial fibrillation. The committee found that the drug, which is being developed by Belgium's Solvay Pharmaceuticals, caused potentially dangerous side effects including ventricular arrhythmia and hypotension.

The committee added that, while the drug had demonstrated efficacy, its complicated dosing schedule and the lack of data supporting its safety had shaped their decision. In particular, the two-step treatment regimen proposed by Solvay was deemed to provide too small a dosage range over which the drug was safe and effective. Committee member Tom Marciniak likened the protocol to "throwing a dart [as to] what the [correct] dose should be."

The reviewers also questioned if the submitted trial data could apply to the US population, given that the vast majority of assessments were conducted outside the country where standards of AF care differ.