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NOV 08, 2013 - Yahoo! News

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FDA staff flag safety fears over Sanofi MS drug Lemtrada

(Reuters) - U.S. regulatory officials have raised concerns about "multiple serious and potentially fatal safety issues" in patients given Sanofi's new multiple sclerosis drug Lemtrada, fuelling uncertainty about whether it will be approved. Food and Drug Administration (FDA) staff said in a report prepared ahead of a November 13 advisory panel that the risks might be too great to justify approval, unless the drug showed "substantial clinical benefit". Shares in Sanofi fell 2 percent after the documents were posted on the FDA's website on Friday. Sanofi acquired it when it bought U.S. biotech ... Read More

Tags: FDA staff flag safety fears over Sanofi MS drug Lemtrada,  Multiple Sclerosis Latest News