FDA: Risks certain, efficacy not for Sanofi/Genzyme MS drug Lemtrada
This article was originally published in Scrip
Executive Summary
The situation looks pretty bleak for the future of Genzyme's Lemtrada (alemtuzumab) heading into a meeting on 13 November of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee after agency reviewers declared the certainty of the medicine's risks may not be balanced by the uncertainty of its potential benefits in treating relapsing forms of multiple sclerosis (RMS).