The CHMP has adopted a positive opinion recommending an EU marketing authorisation for Multaq (dronedarone – 400mg tablets).
The recommendation is for the treatment of adult clinically stable patients with a history of, or current, non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower the ventricular rate.
The CHMP also acknowledged that dronedarone has been shown, in addition to its rhythm and rate controlling properties, to decrease the risk of atrial fibrillation-related hospitalisations.
“Sanofi-aventis welcomes the positive CHMP recommendation for the approval of Multaq in the European Union,” said Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis. “This decision brings new hope to people whose lives are impacted by the potential cardiovascular complications of atrial fibrillation. We do think that Multaq will contribute to fulfill significant unmet medical needs for the patients.”
The positive opinion is based on the submission of a comprehensive clinical data package including seven international clinical trials involving more than 7000 patients and including the ATHENA trial.
The ATHENA trial showed that Multaq, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalisation or death from any cause by 24% when compared to placebo.
Atrial fibrillation is emerging as a public health concern and represents one-third of hospitalisations for arrhythmia in the European Union. It leads to potential life-threatening complications such as increasing the risk of stroke up to five-fold and worsening the prognosis of patients with cardiovascular risk factors.