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FDA approves Sanofi-Aventis' anti-arrhythmic Multaq
Thursday, July 02 2009 | Comments
What's This?
The Food and Drug Administration approved Sanofi-Aventis Group's anti-arrhythmia drug Multaq (dronedarone hydrochloride) for the treatment of patients with atrial fibrillation or atrial flutter.The drug is indicated for use in patients with a history of paroxysmal or persistent atrial fibrillation or atrial flutter who are in sinus rhythm or who will be cardioverted; the approval reflects a reduction in the risk of cardiovascular hospitalization with Multaq in this patient population.
The New Drug Application (NDA) for Multaq was filed in June 2005 based on data from three pivotal trials but received a nonapprovable letter from the FDA in August 2006. The company subsequently refiled the NDA with positive data from the ATHENA trial and received a priority review designation last August.
The double-blind ATHENA trial included 4,628 patients with atrial fibrillation who were randomized to receive Multaq 400 mg twice daily or placebo, both in addition to standard therapy. The primary endpoint was a composite of first hospitalization for cardiovascular events or death from any cause. After a mean follow-up of 21 months, the likelihood of achieving the primary outcome was 24 percent lower among the Multaq-treated patients as compared with the placebo-treated patients.
The drug's label will include a boxed warning that Multaq is not to be used in patients with certain classes of heart failure because of the risk of critical adverse reactions, including death. Specifically, Multaq is contraindicated for use among individuals with severe heart failure--New York Heart Association (NYHA) class IV--or among those with NYHA class II to III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic, Sanofi-Aventis noted.
The company said Multaq will be launched in the United States this summer.
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