Reuters: Regulatory News: UPDATE 1-FDA staff flag safety fears over Sanofi MS drug Lemtrada

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UPDATE 1-FDA staff flag safety fears over Sanofi MS drug Lemtrada Nov 8th 2013, 14:32 Fri Nov 8, 2013 9:32am EST Nov 8 (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 Nov. 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. Lemtrada, also known as alemtuzumab, is given via an intravenous drip for five days and for three days one year later. It is designed to re-programme the immune system. Sanofi acquired it when it bought U.S. biotech firm Genzyme for $20.1 billion in 2011. Lemtrada's prospects were at centre-stage in that drawn-out takeover battle, leading to an eventual deal that included listed contingent value rights linked to Lemtrada's future success.

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