September 28, 2009 – Sanofi-aventis announced last week the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending to grant a marketing authorization in the European Union for Multaq (dronedarone 400mg tablets).
The CHMP has recommended the approval of Multaq in adult clinically stable patients with history of, or current nonpermanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.
In the Summary of Positive Opinion, the CHMP has acknowledged that dronedarone has been shown, in addition to its rhythm and rate controlling properties, to decrease the risk of atrial fibrillation-related hospitalizations.
The positive opinion from the CHMP needs now to be ratified by the European Commission. The opinion is based on the submission of a comprehensive clinical data package including seven international, multicenter, randomized clinical trials involving more than 7,000 patients and including the landmark ATHENA trial.
The ATHENA trial involved 4,628 patients with atrial fibrillation/atrial futter or a recent history of these conditions and showed that Multaq (dronedarone) in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24 percent when compared to placebo, meeting the study’s primary endpoint. Reported significant adverse events in the Multaq arm included diarrhea, nausea, bradycardia, QT-interval prolongation and cutaneous rash.
The incidence of atrial fibrillation is growing worldwide in relation to aging populations. It is emerging as a public health concern and affects about 4.5 million people and represents one-third of hospitalizations for arrhythmia in the European Union.
Multaq recently received approval from the U.S. Food and Drug Administration (FDA), Health Canada and Swissmedic (Swiss Health Authority).