Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone, announced that Multaq (dronedarone) 400 mg tablets has received Health Canada approval for the treatment of patients with a history of, or current atrial fibrillation to reduce their risk of cardiovascular hospitalization due to this condition. This is the second major approval for Multaq this year, following the approval on July 1, 2009 by the US Food and Drug Administration.
"Multaq may help patients with atrial fibrillation stay out of the hospital", said Dr. Jean-Pierre Lehner, chief medical officer, sanofi-aventis. "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 landmark 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 (71% of these patients had no heart failure, 29% were in NYHA class I-III with stable heart failure). This trial showed that Multaq 400 mg 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 in 4,628 patients followed for up to 30 months (median 22 months), meeting the study's primary endpoint.
Initiation of Multaq is contraindicated in patients with severe congestive heart failure (classified as Stage IV by the NYHA or New York Heart Association) and other unstable hemodynamic conditions.
There are approximately 250,000 Canadians with AF and the incidence is growing in relation to the aging population. Atrial fibrillation affects 2.5 million people in the United States and 4.5 million people in the European Union. Atrial fibrillation is a complex disease that increases the risk of stroke up to five-fold, worsens the prognosis of patients with cardiovascular risk factors, and doubles the risk of mortality.
Multaq discovered and developed by sanofi-aventis, has been studied in a clinical development programme involving nearly 6,300 patients including more than 3,200 patients who received Multaq. It represents one of the few new treatment options for AF / AFL patients in the last 20 years. Multaq is to be given twice daily as a 400 mg tablet and should be taken as one tablet with the morning and evening meals. Treatment with Multaq can be initiated in an outpatient setting. Most common adverse reactions are diarrhoea, nausea, vomiting, abdominal pain, asthenia (weakness) and cutaneous rash.
Multaq is contraindicated in patients with severe congestive heart failure (classified as Stage IV by the NYHA or New York Heart Association) and other unstable hemodynamic (cardiovascular) conditions, and should be used with caution in patients with moderate congestive heart failure (NYHA Stage III).