FDA panel backs Lemtrada

FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 12-6 that the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) provided substantial evidence of Lemtrada alemtuzumab's efficacy to treat relapsing multiple sclerosis (MS). Additionally, the panel voted 17-0, with one abstention, that Lemtrada's safety concerns do not preclude approval.

However, if Lemtrada is approved, the panel voted 16-0, with two abstentions, that it should not be indicated as first-line therapy. ...