The latest international trials of the French drugmaker Sanofi-Aventis’ experimental heart drug, dronedarone - Multaq – yielded “promising” outcomes with regard to its testing of irregularity in heartbeat.
According to a report published in the New England Journal of Medicine, the trials conducted on 2,301 people with atrial fibrillation revealed that the need for hospitalization, due to heart attack, stroke, or other such problems, was reduced by 24 percent with the use of dronedarone.
On the basis of the upbeat trials, dronedarone is going to be assessed on a priority basis by the FDA, with the agency’s advisory committee scheduled to meet on March 19 for conferring a likely approval to the drug.
Though there are some concerns regarding the safety of dronedarone, more so as is a chemical relative of amiodarone, Tim Anderson of Sanford Bernstein is of the opinion that “the odds are in favor of the drug getting approved.”
In the opinion of analysts, upon its approval by the FDA advisory committee, the US marketing of dronedarone will begin in this year’s second quarter, with the possibility of the drug meeting European approval in the second half.
Dr. Richard L. Page, head of Cardiology division of School of Medicine, University of Washington, said believes that dronedarone will be “approved favorably,” as “the overall literature on this drug shows both efficacy and safety.” (Harkiran contributed to this report)












