Multaq dronedarone regulatory update

FDA completed a safety review of Sanofi's Multaq dronedarone and recommended against use of Multaq dronedarone to treat permanent atrial fibrillation (AF). The agency said the review showed the multichannel blocker with properties of antiarrhythmics in Vaughan-Williams classes I-IV increased the risk of serious cardiovascular events, including death, when used by patients with permanent AF. The review was based on the Phase IIIb PALLAS trial and the Phase III ATHENA trial (see BioCentury, Dec. 5, 2011).

In July, Sanofi discontinued development of Multaq to treat permanent AF after a significant increase in cardiovascular events in patients receiving Multaq was observed in the PALLAS trial (see BioCentury, July 11, 2011). In September, EMA's CHMP recommended restricting the use of Multaq after finding an increased risk of liver, lung and cardiovascular adverse events associated with the drug (see BioCentury, Sept. 26, 2011). ...