Merck & Co. and partner Cardiome announced Wednesday that EU regulators approved Brinavess (vernakalant) as a treatment for the rapid conversion of recent onset atrial fibrillation (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. The companies said they expected to launch the drug in the fourth quarter.
The approval, which follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use, was based on the results of three placebo-controlled studies and one study comparing the drug to amiodarone.
The approval in this market triggers a $30 million milestone payment from Merck to Cardiome under the terms of a licensing agreement between the two drugmakers.
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