FDA staff flag safety fears over Sanofi MS drug Lemtrada

[riky]

FDA staff flag safety fears over Sanofi MS drug Lemtrada

<p><a href="http://news.yahoo.com/fda-staff-raise-safety-concerns-over-sanofi-ms-141734212--finance.html"><img src="http://l3.yimg.com/bt/api/res/1.2/ijYUvKpNwxjseqUj4oX4KA--/YXBwaWQ9eW5ld3M7Zmk9ZmlsbDtoPTg2O3E9NzU7dz0xMzA-/http://media.zenfs.com/en_us/News/Reuters/2013-11-08T162350Z_1_CBRE9A719JX00_RTROPTP_2_CHINA-PHARMACEUTICALS.JPG" width="130" height="86" alt="Employee walks into an office of French drugmaker Sanofi in Shanghai" align="left" title="Employee walks into an office of French drugmaker Sanofi in Shanghai" border="0" /></a>U.S. regulatory officials have raised concerns about &quot;multiple serious and potentially fatal safety issues&quot; 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 in the world's biggest pharmaceutical market, unless the drug showed &quot;substantial clinical benefit.&quot; Lemtrada, an injectable treatment also known as alemtuzumab, is one of two new Sanofi drugs for MS, an autoimmune disease that attacks the central nervous system and affects more than 2 million people worldwide. The FDA is expected to rule on the drug by the end of the year. Lemtrada won marketing authorization from the European Commission in September, shortly after obtaining approval for its MS pill Aubagio.</p><br clear="all"/>

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