Applications for Lemtrada™
(alemtuzumab), a potential therapy for MS, have been submitted by Genzyme Corp.
to both the U.S. Food and Drug Administration and to European regulators. The
potential MS therapy for relapsing MS is already approved to treat leukemia
under the name Campath®, and Genzyme executives called results from a second
Phase III trial for Lemtrada, released earlier this year,
“unprecedented.”
Genzyme’s clinical development program for
Lemtrada included two Phase III studies in which results for Lemtrada were
superior to Rebif® (high dose subcutaneous interferon beta-1a) on clinical
and imaging endpoints, including a reduction in relapse rate. In addition, as
presented at the 2012 American Academy of Neurology meeting, some patients with
pre-existing disability treated with Lemtrada in the CARE-MS II trial were more
than twice as likely to experience a sustained reduction in disability over two
years than patients treated with Rebif.
Side effects of Lemtrada include potential autoimmune illnesses, including
thyroid disorders and disorders in which the immune system attacks blood
platelets, which can cause bleeding.
The drug is given by daily infusion for
five days, and then daily infusion for three days, 12 months later.
