ARTICLE | Clinical News

Multaq dronedarone regulatory update

July 18, 2011 7:00 AM UTC

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. ...