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Sanofi Has Shown Substantial Evidence Lemtrada Works, Panel Says 2013-11-13 20:46:11.882 GMT
By Catherine Larkin and Meg Tirrell Nov. 13 (Bloomberg) -- FDA advisory panel voted 12-6 that Lemtrada is effective at treating relapsing MS. * 6 dissenters said Sanofi hadn’t proven drug worked because studies weren’t well controlled * Panel will next review whether drug has beneficial effect on disability and whether safety concerns preclude approval * FDA isn’t required to follow panel’s recommendations * NOTE: (Earlier) Sanofi’s Lemtrada Studies Seen Inadequate by FDA Panel
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