26. July 2011 15:36
The EMA has extended its review into the benefits and risks of Sanofi’s Multaq (dronedarone) following the release of new study results.
Preliminary data from the PALLAS study showed an increase in cardiovascular side effects which could affect the use of medicine in its approved indication.
The CHMP says it will now assess all available data in order to finalise the current review in September.
The current assessment of the overall benefit-risk of Multaq began back in January following reports of an associated link to severe liver injury.
The scope of this review has now been extended to include the new information from the PALLAS study which was published in early July.
More than 3,000 patients were enrolled in the study, which investigated patients with permanent atrial fibrillation and cardiovascular risk factors such as cardiovascular death, stroke and cardiovascular hospitalisation.
Multaq has been authorised in the EU since November 2009 and is used in adults who have had an abnormal heart rhythm (atrial fibrillation) in the past or who currently have non-permanent fibrillation.