Multaq dronedarone regulatory update

EMA's CHMP expanded its safety review of Sanofi's Multaq dronedarone after the company discontinued the international Phase IIIb PALLAS trial treat permanent atrial fibrillation (AF) due to a significant increase in cardiovascular events in patients receiving Multaq compared to placebo. In January, CHMP began a review of Multaq following reports of severe liver injury. The agency said it will assess the data from PALLAS and determine the need for further action at its July 18-21 meeting. ...