Genzyme/Sanofi seek 2nd US chance for Lemtrada
This article was originally published in Scrip
Executive Summary
After being rejected this past December by the FDA, Genzyme, a unit of Sanofi, said its plans to resubmit its supplemental biologics license application (sBLA) to the agency for Lemtrada (alemtuzumab) as a treatment for relapsing forms of multiple sclerosis, rather than appealing the complete response letter (CRL) it received.