Dronedarone recommended for approval in the European Union


Sanofi-Aventis announced on 25 September 2009 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending granting a marketing authorisation 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 non-permanent 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 hospitalisations. The positive opinion from the CHMP needs now to be ratified by the European Commission.

“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 CHMP positive opinion is based on the submission of a comprehensive clinical data package including seven international, multicentre, randomised 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 flutter or a recent history of these conditions and showed that dronedarone in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalisation or death from any cause by 24% (p<0.001) when compared to placebo, meeting the study’s primary endpoint. Reported significant adverse events in the Multaq arm included diarrhoea, 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 hospitalisations for arrhythmia in the European Union. Atrial fibrillation leads to potential life-threatening complications. AF increases the risk of stroke up to five-fold, worsens the prognosis of patients with cardiovascular risk factors, and doubles the risk of mortality with significant burden on patients, health care providers and payers.

Multaq has recently received approval from the US FDA, Health Canada and Swissmedic (Swiss Health Authority).