Sanofi-aventis has announced that 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 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 company claims that CHMP positive opinion is based on the submission of a clinical data package including seven international, multi-center, randomized clinical trials, involving over 7000 patients and including the landmark ATHENA trial.
The company said that ATHENA trial involved 4,628 patients with Atrial Fibrillation /Atrial Futter or a recent history of the conditions. It showed that Multaq (dronedarone), in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization 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 diarrhea, nausea, bradycardia, QT-interval prolongation and cutaneous rash.
Jean-Pierre Lehner, chief medical officer of Sanofi-aventis, said: “Sanofi-aventis welcomes the positive CHMP recommendation for the approval of Multaq in the European Union. 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.”