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.
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.”
The efficacy of vernakalant was evaluated at 90 minutes in a total of 390 haemodynamically stable adult patients with short duration atrial fibrillation (3 hours to 7 days). In these studies, treatment with vernakalant effectively converted atrial fibrillation to sinus rhythm as compared with placebo. In one study, ACT I, vernakalant cardioverted 51 percent of patients versus four percent of patients taking placebo (p value <0.0001). In another study, ACT III, vernakalant cardioverted 51.2 percent of patients versus 3.6 percent of patients taking placebo (p value <0.0001). Conversion of atrial fibrillation to sinus rhythm occurred rapidly (in responders the median time to conversion was 10 minutes from start of first infusion). In the AVRO study, vernakalant was studied in 116 pts with atrial fibrillation (3 hrs to 48 hrs) versus 116 patients on amiodarone. The amiodarone infusion was given over two hours (i.e., one hour loading dose of 5 mg/kg, followed by one hour maintenance infusion of 50 mg) with the objective to compare rapid conversion to sinus rhythm. The primary endpoint was the proportion of patients that achieved sinus rhythm (SR) within the first 90 minutes after initiating therapy. In this study, treatment with vernakalant, converted 51.7 percent of patients to SR at 90 minutes versus 5.2 percent with amiodarone resulting in a significantly faster conversion rate from AF to SR within the first 90 minutes compared to amiodarone (log-rank P-value <0.0001).