Merck (known as MSD outside the United States and Canada) (NYSE:MRK) and Cardiome Pharma Corp. (NASDAQ: CRME/ TSX: COM) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for BRINAVESS® (vernakalant), an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.
“Vernakalant has a unique mechanism of action. If approved in the EU, it will become a new therapy for physicians and hospitals to use for the rapid treatment of recent onset atrial fibrillation”
The CHMP issued the positive opinion following a review of data supporting the efficacy, safety and tolerability profile of vernakalant. The proposed indication for vernakalant is for the rapid conversion of recent onset of atrial fibrillation to sinus rhythm in adults: for non-surgery patients with atrial fibrillation of seven days or less and for post-cardiac surgery patients with atrial fibrillation of three days or less.
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. If approved by the European Commission, vernakalant would be the first product in a new class of pharmacologic agents for cardioversion of atrial fibrillation to launch in the EU.
"Vernakalant has a unique mechanism of action. If approved in the EU, it will become a new therapy for physicians and hospitals to use for the rapid treatment of recent onset atrial fibrillation," said Michael E. Mendelsohn, M.D. senior vice president and Head of Cardiovascular Research, Merck Research Laboratories. "Merck is deeply committed to cardiovascular research and we look forward to the European Commission's decision on vernakalant."
"Cardiome welcomes the positive CHMP recommendation," stated Doug Janzen, President and Chief Executive Officer of Cardiome. "Approval of vernakalant will be a significant event for Cardiome and our shareholders and we look forward to authorization by the European Commission."
Merck and Cardiome Pharma Corp.