A-fib drug vernakalant gets EU thumbs up

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended marketing approval for Merck and Cardiome Pharma’s Brinavess (vernakalant), an investigational IV formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

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 AF to sinus rhythm in adults: For non-surgery patients with AF of seven days or less and for post-cardiac surgery patients with AF of three days or less.

If approved by the European Commission, vernakalant would be the first product in a new class of pharmacologic agents for cardioversion of AF to launch in the EU, according to the Whitehouse Station, N.J.-based Merck and the Vancouver-based Cardiome.