EU goedkeuring vernakalant voor AF conversie
EU clears vernakalant for AF conversionSeptember 9, 2010
London, UK - A novel intravenous drug, vernakalant (Brinavess, Merck/Cardiome Pharma), has been approved by the EMA in the European Union, Iceland, and Norway for the rapid conversion of recent-onset atrial fibrillation (AF) to sinus rhythm in adults: for nonsurgical patients with AF of duration seven days or less and for post-cardiac-surgery patients with AF of duration three days or less.
Vernakalant is the first in a class of new pharmacologic agents developed for the acute conversion of AF and works by blocking early-activating K+ channels and frequency-dependent Na+ channels.
Regulatory approval is based on the results of four trials: AVRO, reported at the Heart Rhythm Society meeting this year, in which vernakalant was shown to be more effective than an active comparator, amiodarone, for the rapid conversion of AF to sinus rhythm and to yield a higher rate of symptom relief; and three randomized, double-blind, placebo-controlled studies, ACT I, ACT II, and ACT III.
Vernakalant is still not approved in the US, however, despite an FDA advisory committee having voted to recommend approval almost three years ago, in December 2007; the agency requested more information on the drug, which is to be marketed in North America by Cardiome and Astellas.
Guy Cipriani (Cardiome, Vancouver, BC) told that an additional phase 3 study, ACT V, was initiated in October 2009 to address the FDA's concerns about vernakalant, which were detailed in an approvable letter dated August 2008. Act V is expected to be completed in the first half of 2011, he says.