FDA panel backs narrow Multaq label

FDA's Cardiovascular and Renal Drugs Advisory Committee voted 10-3 on Wednesday to recommend approval of Multaq dronedarone from sanofi-aventis (Euronext:SAN; NYSE:SNY) to treat patients with non-permanent atrial fibrillation (AF). However, the panel agreed that the label for the multichannel blocker with class I-IV antiarrhythmic properties should only support the claim that Multaq reduces cardiovascular hospitalization related to AF. The panel did not support the mortality claims sought by the pharma and felt that the label should include a boxed warning that excludes patients with characteristics similar to those in the Phase III ANDROMEDA trial. The committee based its decision on the Phase III ATHENA and ANDROMEDA trials. In ATHENA, Multaq showed a 24% decrease in the risk of cardiovascular hospitalizations or death from any cause vs. placebo. However, the compound missed the primary endpoint of significant improvement in all-cause mortality or hospitalization for worsening heart failure vs. placebo in the ANDROMEDA study, which enrolled high-risk patients with congestive heart failure (CHF) and ventricular dysfunction.

The panel also suggested that the company do a post-marketing pharmacokinetic study in minority populations and monitor the long-term effects of Multaq. ...