CHMP: positief advies voor vernakalant iv bij AFNieuws - June 28, 2010
EMEA registreert vernakalant voor atrium fibrilleren
Whitehouse Station, N.J. U.S.A. and Vancouver, Canada, June 25, 2010 — MSD and Cardiome Pharma Corp. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for vernakalant, an investigational intravenous (IV) formulation for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.
The 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 atrial fibrillation to sinus rhythm in adults: for non-surgery patients with atrial fibrillation of seven days or less and for post-cardiac surgery patients with atrial fibrillation of three days or less.
SOURCE: Cardiome Pharma Corp.