An anti-arrhythmic drug used in the treatment of atrial fibrillation (AF), dronedarone (Multaq; Sanofi-aventis), has been approved in all 27 European member states by the European Commission.
Dronedarone, available in 400 mg tablets, is administered to clinically stable patients with a history of, or current non-permanent AF to prevent recurrence of AF or to lower ventricular rate.
The authorization comes shortly after a positive opinion of the drug was issued Sept. 25, 2009, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMEA).
According to the Paris-based company, the approval is based on the results from seven international clinical trials involving 7,000 patients. An ATHENA study showed that after a 30-month follow up of 4,628 AF and atrial flutter patients, cardiovascular hospitalizations and death occurred 24 percent less in patients administered dronedarone than in those administered a placebo.
"This European approval is good news for doctors and patients since atrial fibrillation affects about 4.5 million people in Europe and represents one-third of hospitalizations for arrhythmia in the European Union," said Stefan H. Hohnloser, MD, from J.W. Goethe University’s division of clinical electrophysiology in Frankfurt, Germany, and lead author of the ATHENA trial.
The drug has already been approved in the U.S., Canada, Switzerland and Brazil, and is expected to be initially released in the U.K. and Germany in January.