June 25, 2010 - Investigational BRINAVESS™ (vernakalant) for Infusion Recommended for Approval by the CHMP in the European Union (EU) for the Rapid Conversion of Recent Onset Atrial Fibrillation — Merck (known as MSD outside the United States and Canada) (NYSE:MRK) and Cardiome Pharma Corp. (NASDAQ: CRME/ TSX: COM) 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.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... Cardiome Pharma's Press Release -
