Brinavess is an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.
Merck and Cardiome Pharma said that the CHMP has issued its positive opinion depending on the 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.
Merck and Cardiome Pharma are expected to get the final marketing authorisation by the European Commission later this year and will apply to the 27 countries that are members of the EU plus Norway and Iceland.
Michael Mendelsohn, senior vice president and head of cardiovascular research of research laboratories at Merck, said: “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. Merck is deeply committed to cardiovascular research and we look forward to the European Commission’s decision on vernakalant.”
Doug Janzen, president and CEO of Cardiome, said: “Cardiome welcomes the positive CHMP recommendation. Approval of vernakalant will be a significant event for Cardiome and our shareholders and we look forward to authorization by the European Commission.”