US FDA to Sanofi/Genzyme: Get organized on Lemtrada application
This article was originally published in Scrip
Executive Summary
Genzyme's US supplemental biologics license application (sBLA) for Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis hit some rough waters at the US FDA, which told the Sanofi subsidiary to reorganize its sBLA so regulators could better navigate it.