FDA panel gives nod to Sanofi's Multaq
A panel of experts convened by the US Food and Drug Administration has recommended that French drug major Sanofi-Aventis' Multaq (dronedarone) be approved for atrial fibrillation. The FDA's Cardiovascular and Renal Drugs Advisory Committee voted 10 to three in favor of authorizing Multaq to treat patients with non-permanent AF.
The drug, which was rejected in 2006 amid safety concerns, could boost Sanofi's ailing portfolio after a number of recent setbacks. If it reaches the market, some analysts forecast it could generate over $2.0 billion a year. A blockbuster drug will help the Paris-based company replace the 35% of sales that it will lose between now and 2012 due to patent expiries on several major compounds.
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