Multaq (dronedarone) 400mg tablets will now be available as treatment to reduce the risk of cardiovascular hospitalisation.
Sanofi-Aventis chief medical officer Jean-Pierre Lehner said that Multaq may help patients with AF stay out of the hospital.
“We are pleased that Health Canada has approved Multaq as a new treatment option that may help patients with AF manage their condition and may overall help reduce the burden of the disease,” Lehner said.
Multaq received approval from the US Food and Drug Administration on 1 July 2009 based on the results of the ATHENA trial, which showed that Multaq 400mg BID, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalisation or death from any cause by 24% when compared to placebo.
The trial was conducted on 4,628 patients over 30 months.