Merck & Co and partner Cardiome Pharma Corp have been granted marketing approval by European regulators for the intravenous formulation of their anti-arrhythmic Brinavess.
The European Union, Iceland and Norway have given the green light to Brinavess (vernakalant) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults. It can be used 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 approval, which was expected following a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use in June, was based on the results of three placebo-controlled studies and one trial comparing vernakalant to the gold standard treatment amiodarone.
Patrick Magri, head of the cardiovascular franchise at Merck said Brinavess represents a major addition to "our strong portfolio of medicines for cardiovascular disease". He added that European launches will begin in the fourth quarter.
Cardiome, which is based in Vancouver, Canada, is clearly delighted as Brinavess "will provide us with our first commercial product revenues,” said chief executive Doug Janzen. The European approval has also triggered a $30 milestone payment from Merck under the terms of the pact they signed in April last year.