FDA staff says new oral MS drug Lemtrada may be too risky

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FDA staff says new oral MS drug Lemtrada may be too risky

Post by MSUK » Fri Nov 08, 2013 8:26 am

Sanofi’s multiple sclerosis treatment Lemtrada may not offer enough benefit to patients to outweigh risks including cancer, U.S. regulators said. The French drugmaker’s shares fell.

Lemtrada’s “serious and potentially fatal safety issues,” which include the risk of autoimmune and thyroid diseases, may make the medicine too dangerous to approve unless there is substantial clinical benefit shown, Food and Drug Administration staff said in a report today. Agency reviewers also questioned whether Sanofi conducted adequate trials to prove the annual infusion works.

“That’s like a death sentence,” said Fabian Wenner, an analyst with Kepler Cheuvreux in Zurich, “It isn’t what everyone expected, an issue with the safety. It seems to be a more fundamental issue here.” - Read More- http://www.ms-uk.org/lemtrada
MS-UK - http://www.ms-uk.org/

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Re: FDA staff says new oral MS drug Lemtrada may be too risk

Post by SarahLonglands » Fri Nov 15, 2013 10:04 am

This original posting about Lemtrada seems more accurate than the new one you posted yesterday...............Sarah
An Itinerary in Light and Shadow Completed Dr Charles Stratton / Dr David Wheldon abx regime for aggressive secondary progressive MS in June 2007, after four years. Still improving with no relapses since starting. Can't run but can paint all day.

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