The Cardiovascular and Renal Drugs Advisory Committee of the FDA on Tuesday has recommended that the FDA approve Cardiome Pharma and its co-development partner Astellas Pharma’s Kynapid, the intravenous formulation of vernakalant hydrochloride, an investigational new drug for rapid conversion of acute atrial fibrillation (AF).
At the panel review, the members voted 6 to 2 in favor of recommending to the FDA that Kynapid be approved for the rapid conversion of acute AF to sinus rhythm. If approved, Kynapid will be the first pharmacologic therapy for the conversion of AF in eight years, according to the Vancouver, British Columbia-based Cardiome and the Deerfield, Ill.-based Astellas.
The companies reported that further response to the FDA action of Kynapid is expected on or before Jan. 19, 2008.
Kynapid is the proposed U.S. brand name for the intravenous formulation vernakalant hydrochloride.
In October 2003, Cardiome said it granted Astellas Pharma an exclusive license to develop and commercialize Kynapid in North America. Cardiome has retained all rights to the intravenous formulations outside of Canada, the United States and Mexico. Upon approval, Astellas Pharma will market Kynapid in the United States.