Cardiome/Astellas' Kynapid gets nod from FDA c'ttee

USA-based Cardiome Pharma Corp and the local unit of Japanese drug major Astellas say that the Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration has recommended the approval of Kynapid, an intravenous formulation of vernakalant HCl, an investigational new drug for rapid conversion of acute atrial fibrillation.

At the panel review, members voted six to two in favor of recommending to the FDA that Kynapid be approved for the rapid conversion of acute AF to sinus rhythm. If cleared, the agent will be the first new pharmacologic therapy for the conversion of AF in eight years. Action further to the FDA review is expected on or before January 19, 2008, the firms noted.