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 what could be a window