Multaq Receives Approval In Canada For Atrial Fibrillation

Sanofi-aventis has announced that Multaq (dronedarone) 400mg tablets received Health Canada approval for the treatment of patients with atrial fibrillation, to reduce their risk of cardiovascular hospitalization. Multaq had received approval from the US Food and Drug Administration on July 1, 2009.

Jean-Pierre Lehner, chief medical officer of Sanofi-aventis, said: “Multaq may help patients with atrial fibrillation stay out of the hospital. We, as a company are pleased that Health Canada has approved Multaq as a new treatment option that may help patients with atrial fibrillation manage their condition and may overall help reduce the burden of the disease.”

In the ATHENA trial, the efficacy and safety of Multaq was evaluated in patients with atrial fibrillation/atrial flutter (AF/AFL) or a recent history of these conditions. The trial showed that Multaq 400mg BID, 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. It was conducted on 4,628 patients followed for up to 30 months (median 22 months), therby meeting the study’s primary endpoint.