The FDA's cardiology drug panel voted 10-3 this Wednesday to approve Sanofi-Aventis' Multaq (dronedarone) to treat patients with non-permanent atrial fibrillation (AF)--the first new treatment in 25 years.
However, panel members said that the drug should not be prescribed to patients with severe heart failure and Sanofi should not be allowed to claim the medicine reduces the risk of death, according to Reuters.
The panel took into consideration the <a href=" http://www.cardiovascularbusiness.com/index.php?option=com_articles&... target="_blank" ><span style="text-decoration: underline;" >results of the ATHENA trial which found that Multaq, in addition to standard therapy, significantly reduced the risk of first cardiovascular hospitalization or death by 24 percent in patients with AF or a recent history of these conditions. The trial evaluated the use of Multaq in 4,628 patients with AF who had additional risk factors for death. While the trial found a decrease in hospitalizations, the evidence was "not convincing" it reduces deaths--as Sanofi had requested--according to an FDA report.
The FDA is not bound by the committee's recommendation, but usually takes its advice into consideration when reviewing new drug applications. The agency is scheduled to make a final decision by April 30.
AF is the leading cause of hospitalization for arrhythmia in the U.S. and represents one-third of hospitalizations for arrhythmia in Europe. The Paris-based Sanofi also reported that there are approximately 2.5 million Americans and 4.5 million people in the European Union with AF and it is emerging as a growing public health concern due to an aging population.