Multaq, Sanofi-Aventis’s treatment for heart-rhythm disorders, has made a comeback . Rejected by the FDA in 2006 because of safety concerns, the agency has approved Multaq, the company announced today. The drug approval is the French drug maker’s first major U.S. approval in seven years, according to Bloomberg . Late last year, Sanofi decided to discontinue development of obesity drug Acomplia, which was once thought to have much promise. Lately, the company has faced questions lately about whether its diabetes drug, Lantus, is linked to cancer . Sanofi has predicted that Multaq, which treats atrial fibrillation and atrial flutter, eventually will bring in annual sales of more than $1 billion, notes Dow Jones Newswires . The FDA

rejected Sanofi’s initial attempt for approval because a study showed that patients on Multaq were more likely to die than those who received a placebo. The company has since conducted more research looking at patients at a less-advanced stage of heart disease. Sanofi will also implement a risk evaluation and mitigation strategy to help “ensure the safe use of Multaq” and help health-care workers identify patients appropriate for the treatment, according to the company. “The drug is now approved, ending Sanofi’s streak of pipeline futility,” UBS analyst Gbola Amusa told Dow Jones. Image courtesy of Columbia University Medical Center

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Multaq Approval Marks Comeback for Sanofi’s Heart Drug