Cardiome drug clears European committee

The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing approval for Cardiome Pharma’s (TSX:COM; NASDAQ:CRME) vernakalant, an investigational intravenous formulation for the conversion of atrial fibrillation to normal heart rhythm in adults.

Granting of marketing authorization by the European Commission is expected later this year and will apply to the 27 countries that are members of the EU plus Norway and Iceland.

“Cardiome welcomes the positive committee recommendation,” CEO Doug Janzen said in a statement. “Approval of vernakalant will be a significant event for Cardiome and our shareholders, and we look forward to authorization by the European Commission.”

Added Dr. Michael Mendelsohn, senior vice president and head of cardiovascular research for Merck Research Laboratories:, “If approved in the EU, vernakalant will become a new therapy for physicians and hospitals to use for the rapid treatment of recent onset atrial fibrillation.”

In April 2009, Cardiome and Merck (NYSE: MRK) announced a collaboration and license agreement for the development and commercialization of vernakalant.