Multaq REMS May Be Revamped As Label Adds New Risks
This article was originally published in The Pink Sheet Daily
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.
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Higher regulatory hurdles for anti-arrhythmic drugs have pushed Merck to discontinue the development of Cardiome’s oral vernakalant.
While giving it a positive risk/benefit balance, EMA says other anti-arrhythmic medicines should be considered before Sanofi's Multaq, potentially heralding its demise in Europe.
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.