Merck & Co. and Cardiome announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion to recommend approval of Brinavess (vernakalant) as a treatment for atrial fibrillation (AF). If approved later this year, the drug will be the "first product in a new class of pharmacologic agents for cardioversion of atrial fibrillation to launch in the EU," according to Merck.
The CHMP recommended approval of the intravenous formulation of Brinavess for the rapid conversion of recent onset of AF fibrillation to sinus rhythm in adults. In clinical studies involving 390 adult patients with short duration AF, Merck said that treatment with the drug "effectively converted" AF to a normal rhythm as compared to placebo.
Last year, Merck gained rights outside of North America to the intravenous formulation of Brinavess from Cardiome. The $600-million deal also gave Merck global rights to the oral formulation of the drug, which the companies are developing as a maintenance treatment for normal heart rhythm in patients with AF.
A competing drug, sanofi-aventis' Multaq (dronedarone), was approved last November in the EU as a treatment to prevent recurrence of atrial fibrillation.
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