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Lemtrada Advisory Committee’s Flexibility May Not Make FDA Bend

 
• By Sarah Karlin-Smith

Panel agrees with agency that Genzyme’s pivotal trials for MS drug don’t meet FDA approval standards, then casts conflicting votes supporting drug.

FDA’s Peripheral and Central Nervous System cast a potentially fatal vote Nov. 13, agreeing with the agency that Genzyme Corp./Sanofi’s pivotal trials for multiple sclerosis candidate Lemtrada (alemtuzumab) were not adequate and well-controlled – necessary qualifications for drug approval.

But the panel quickly followed that vote with a supportive vote on the drug’s efficacy and later a vote that safety concerns associated with the biologic didn’t preclude approval, offering...

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