Multaq Panel Resolves Mortality Concerns, Looks At Restricted Claims
With two sets of conflicting data in front of them, the Cardiovascular and Renal Drugs Advisory Committee's first task for its review of Sanofi-Aventis' Multaq was to determine if the results were compatible. In the end, swayed by the positive findings in a narrower population, the committee supported a limited approval for dronedarone
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After several years of regulatory struggles Sanofi’s anti-arrhythmic Multaq finally got to market. But results from a new study have drawn attention to safety problems in higher-risk patients and could damage the drug’s commercial opportunity.
The Phase IIIb trial was in patients who had had atrial fibrillation for at least six months; an earlier trial in heart failure also was terminated because of increased risk.
Sanofi is facing another safety issue with its antiarrhythmic drug Multaq (dronedarone) with the termination of a Phase IIIb clinical trial in patients with permanent atrial fibrillation due to an increase in cardiovascular events.