Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) has announced that the Cardiovascular and Renal Drugs Advisory Committee voted 10 to 3 in favor of the approval of Multaq by the U.S. Food and Drug Administration (FDA) to treat patients with non permanent atrial fibrillation (AF).
As demonstrated in the ATHENA trial, Multaq is the only anti-arrhythmic drug to have shown in a clinical study a significant reduction in morbidity and mortality in patients with atrial fibrillation/atrial flutter (AFL) or a recent history of these conditions.
“Sanofi-aventis is pleased with the outcome of todays discussions and positive recommendation, said Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis. The panels insightful feedback which concluded with a positive vote, is an important step in gaining FDA approval of Multaq.
The FDA is not bound by the Committees recommendation, but it takes its advice into consideration when reviewing new drug applications.
Atrial fibrillation is the leading cause of hospitalisation for arrhythmia in the U.S. and represents one-third of hospitalisations for arrhythmia in Europe. Hospitalization due to AF has increased dramatically (two-to-three fold) in recent years in the U.S. 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. There are approximately 2.5 million Americans and 4.5 million people in the European Union with atrial fibrillation and it is emerging as a growing public health concern due to
an aging population.