FDA Advisory Panel Gives Mixed Votes To Genzyme’s Proposed MS Drug Lemtrada

A Food and Drug Administration advisory panel Nov. 13 gave mixed votes to Genzyme Corp.'s proposed multiple sclerosis drug Lemtrada (alemtuzumab) injection.

Alemtuzumab is a leukemia drug sold under the brand Campath that also is being developed for MS under the name Lemtrada. Specifically, Genzyme is seeking approval of Lemtrada for patients with relapsing forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations.

The Peripheral and Central Nervous System Drugs Advisory Committee voted 12-6 that Genzyme has provided substantial evidence of Lemtrada’s effectiveness for patients with relapsing forms ...